Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004748528

FEI Number

3004748528

Entity Name

SHANGHAI JPY ION-TECH CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE, SHANGHAI 201707, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

SHANGHAI JPY ION-TECH CO., LTD. (Owner Number: 9066119)

Owner / Operator Contact Address

NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE, SHANGHAI, CN-NOTA 201707, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VANGUARD CR ILOK FEM-RT 67.5 VANGUARD CR ILOK FEM-RT 65 VNGD CR INTLK FEMORAL 55MM RT VANGUARD CR ILOK FEM-LT 67.5 VAN PS OPEN INTL FEM-RT 72.5 VAN PS OPEN INTL FEM-RT 67.5 VAN PS OPEN INTL FEM-LT 60 VANGUARD CR ILOK FEM-RT 60 VNGD PS OPEN INTL FEM RT 70 VAN PS OPEN INTL FEM-LT 67.5 VNGD PS OPEN INTL FEM-RT 57.5 VANGUARD CR ILOK FEM-LT 57.5 VANGUARD CR ILOK FEM-LT 80 VANGUARD CR ILOK FEM-RT 57.5 VAN PS OPEN INTL FEM-LT 65 VANGUARD CR ILOK FEM-LT 70 VANGUARD CR ILOK FEM-LT 62.5 VAN PS OPEN INTL FEM-LT 72.5 VANGUARD CR ILOK FEM-RT 72.5 VANGUARD CR ILOK FEM-LT 65 VAN PS OPEN INTL FEM-LT 80 VAN PS OPEN INTL FEM-RT 62.5 VANGUARD CR ILOK FEM-RT 70 VAN PS OPEN INTL FEM-LT 55 VNGD PS OPEN INTL FEM RT 55 VANGUARD CR ILOK FEM-LT 72.5 VAN PS OPEN INTL FEM-LT 70 VANGUARD CR ILOK FEM-LT 60 VANGUARD CR ILOK FEM-LT 75 VNGD PS OPEN INTL FEM RT 75 VAN PS OPEN INTL FEM-LT 75 VANGUARD CR ILOK FEM-RT 80 VAN PS OPEN INTL FEM-RT 80 VANGUARD CR ILOK FEM-LT 55 VNGD PS OPEN INTL FEM RT 60 VANGUARD CR ILOK FEM-RT 75 VAN PS OPEN INTL FEM-LT 57.5 VAN PS OPEN INTL FEM-RT 65 VAN PS OPEN INTL FEM-LT 62.5 VANGUARD CR ILOK FEM-RT 62.5 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 60MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 65MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 75MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 55MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 70MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 70MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 67.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 67.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 80MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 57.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 72.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 60MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 75MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 55MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 62.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 65MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 72.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL RT 62.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 57.5MM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained / VANG SSK 360/DA360 COCR FMRL LT 80MM GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD Global Advantage extended humeral head CTA Head ACTIS COLLARED HIGH SIZE 4 ACTIS COLLARED HIGH SIZE 3 ACTIS COLLARED HIGH SIZE 8 ACTIS COLLARED STD SIZE 11 ACTIS COLLARED HIGH SIZE 5 ACTIS COLLARED HIGH SIZE 12 ACTIS COLLARED STD SIZE 0 ACTIS COLLARED STD SIZE 2 ACTIS COLLARED STD SIZE 8 ACTIS COLLARED STD SIZE 6 ACTIS COLLARED STD SIZE 9 ACTIS COLLARED STD SIZE 4 ACTIS COLLARED HIGH SIZE 2 ACTIS COLLARED STD SIZE 5 ACTIS COLLARED HIGH SIZE 1 ACTIS COLLARED STD SIZE 1 ACTIS COLLARED HIGH SIZE 0 ACTIS COLLARED STD SIZE 7 ACTIS COLLARED STD SIZE 3 ACTIS COLLARED HIGH SIZE 7 Actis DuoFix Hip Prosthesis ACTIS COLLARED HIGH SIZE 9 ACTIS COLLARED HIGH SIZE 11 ACTIS COLLARED HIGH SIZE 10 ACTIS COLLARED STD SIZE 10 ACTIS COLLARED HIGH SIZE 6 ACTIS COLLARED STD SIZE 12 OMNI PLUS Surgical System - sterile, single-use device transducer, pressure, catheter tip Charnley ORTRON 90* HIP PROSTHESIS EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM Plate, Fixation, Bone CSTEM AMT DEPUY C-STEM AMT HIP PROSTHESIS LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, BONE SCR 6.5 X 40 SELF-TAP BONE SCR 4.5 X 40 SELF-TAP BONE SCR 6.5 X 80 SELF-TAP BONE SCR 6.5 X 20 SELF-TAP BONE SCR 4.5 X 20 SELF-TAP BONE SCR 4.5 X 25 SELF-TAP BONE SCR 6.5 X 35 SELF-TAP BONE SCR 4.5 X 50 SELF-TAP BONE SCR 6.5 X 70 SELF-TAP BONE SCR 4.5 X 30 SELF-TAP BONE SCR 6.5 X 25 SELF-TAP BONE SCR 6.5 X 50 SELF-TAP BONE SCR 6.5 X 60 SELF-TAP BONE SCR 6.5 X 30 SELF-TAP BONE SCR 6.5 X 15 SELF-TAP BONE SCR 4.5 X 60 SELF-TAP BONE SCR 4.5 X 35 SELF-TAP BONE SCR 4.5 X 15 SELF-TAP MODIFIED AML + ACETABULAR CUP PROSTHESIS Gam Brand Item No:650-3001-0100 Dukal Brand Item No:7305 25MM VERSA-DIAL TAPER ADAPTOR Medline E-Z Lubricating Jelly Foil Pack 2.7G Lubricating Jelly Medline E-Z Lubricating Jelly Foil Pack 5G DePuy Actis DuoFix Hip Prosthesis Affixus Tibial and Antegrade Femoral Nailing System P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) PFC Sigma APT STB Insert CATHETER CONNECTIONS' DUALCAP DUO Synapse system Acti-Lance baby Duraloc DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM SIGMA TIBIAL INSERTS DISPOSABLE GENERAL AND PLASTIC SUR GERY Medline Needle Counter TPRLC 133 FP TYPE1 PPS HO 18 Attune Dome Patella, ATTUNE MEDIAL DOME PAT 32MM Attune Dome Patella, ATTUNE MEDIAL DOME PAT 38MM Attune Dome Patella, ATTUNE MEDIAL DOME PAT 29MM Attune Dome Patella, ATTUNE MEDIAL DOME PAT 41MM Attune Dome Patella, ATTUNE MEDIAL DOME PAT 35MM LCS(R) TOTAL KNEE SYSTEM Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED PFC Sigma APT STB Insert Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Hypodermic Single Lumen Needle Allevyn Ag Dressings Allevyn Ag Adhesive DEPUY DURALOC ACETABULAR CUP SYSTEM TPRLC 133 FP 12/14 PPS HO 11 TPRLC 133 FP 12/14 PPS SO 18 TPRLC 133 FP 12/14 PPS HO 18 MERLIN SPINE SYSTEM PFC Mod. Tibial Tray P.F.C.(TM) MODULAR KNEE SYSTEM Sof-Form conforming bandage Supra-Form conforming bandage GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE KNEE PROSTHESIS-TIBIAL COMPONENT Biomet Proximal Humerus Plating System DEPUY SIGMA XLK TIBIAL INSERTS CATHETER CONNECTIONS' DUALCAP DEPUY M-SPEC 36MM FEMORAL HEADS 25MM VERSA-DIAL TAPER ADAPTOR DEPUY ATTUNE KNEE SYSTEM ANATOMIC LOCKING PLATING SYSTEM ARTICUL/EZE ARTICUL/EZE FEMORAL HEADS P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM Summit Hip System ELITE MODULAR HIP SYSTEM DYNACOR LUBRICATION GEL TPRLC 133 MP TYPE1 PPS SO 18 TLOC 133 MP SP T1 PPS HO 7X99 TPRLC 133 MP TYPE1 PPS HO 12 TPRLC 133 MP TYPE1 PPS SO 14 TLOC 133 MP SP T1 PPS HO 8X101 TPRLC 133 MP TYPE1 PPS HO 22 TPRLC 133 MP TYPE1 PPS SO 22 TPRLC 133 MP TYPE1 PPS SO 9 TPRLC 133 MP TYPE1 PPS HO 13 TPRLC 133 MP TYPE1 PPS HO 24 TPRLC 133 MP TYPE1 PPS HO 9 TPRLC 133 MP TYPE1 PPS SO 11 TPRLC 133 MP T1 PPS SO 8X101MM TLOC 133 MP SP T1 PPS HO 5X95 TPRLC133 MP T1 PPS SO 6X97.5MM TPRLC 133 MP TYPE1 PPS HO 14 TLOC 133 MP SP T1 PPS HO 6X97.5 TPRLC 133 MP TYPE1 PPS HO 10 TPRLC 133 MP TYPE1 PPS SO 20 TPRLC 133 MP TYPE1 PPS HO 18 TPRLC 133 MP TYPE1 PPS HO 11 TPRLC 133 MP T1 PPS SO 5X95MM TPRLC 133 MP TYPE1 PPS SO 12 TPRLC 133 MP TYPE1 PPS SO 13 TPRLC 133 MP TYPE1 PPS SO 16 TPRLC 133 MP TYPE1 PPS SO 15 TPRLC 133 MP TYPE1 PPS HO 15 TPRLC 133 MP TYPE1 PPS HO 16 TPRLC 133 MP TYPE1 PPS SO 17 TPRLC 133 MP TYPE1 PPS SO 10 TPRLC 133 MP TYPE1 PPS SO 24 TPRLC 133 MP T1 PPS SO 7X99MM TPRLC 133 MP TYPE1 PPS HO 20 Hypodermic Single Lumen Needle CERAMAX CERAMIC HIP SYSTEM PINNACLE 100 ACET CUP 62MM PINNACLE 100 ACET CUP 64MM PINNACLE SECTOR II CUP 52MM PINNACLE 100 ACET CUP 52MM PINNACLE SECTOR II CUP 58MM PINNACLE 100 ACET CUP 60MM PINNACLE 100 ACET CUP 66MM PINNACLE SECTOR II CUP 64MM PINNACLE 100 ACET CUP 48MM PINNACLE SECTOR II CUP 54MM PINNACLE SECTOR II CUP 66MM PINNACLE 100 ACET CUP 50MM PINNACLE SECTOR II CUP 62MM PINNACLE SECTOR II CUP 48MM PINNACLE SECTOR II CUP 50MM PINNACLE SECTOR II CUP 60MM PINNACLE SECTOR II CUP 56MM PINNACLE 100 ACET CUP 56MM PINNACLE 100 ACET CUP 58MM PINNACLE 100 ACET CUP 54MM EFFECTIV-CAP for Needleless Valve TPRLC XR FP TYPE1 PPS 7X134MM TPRLC XR MP FP T1 PPS 8X101MM TPRLC XR T1 PPS 18X156MM TPRLC XR MP T1 PPS 10X105MM TPRLC XR T1 PPS 10X140MM TPRLC 133 MP TYPE1 PPS SO 4 TPRLC XR T1 PPS 17X154MM TPRLC 133 T1 PPS SO 13X146MMTP TPRLC XR T1 PPS 15X150MM TPRLC XR MP T1 PPS 9X102.5MM TPRLC XR T1 PPS 12X144MM TPRLC XR MP T1 PPS 16X117MM TPRLC XR MP T1 PPS 15X115MM TPRLC XR FP TYPE1 PPS 5X130MM TPRLC XR T1 PPS 11X142MM TPRLC XR MP T1 PPS 17X119MM TPRLC XR MP FP T1 PPS 4X93MM TPRLC XR MP FP T1 PPS 7X99MM TPRLC XR T1 PPS 9X137MM TPRLC XR MP T1 PPS 18X121MM TPRLC XR MP FP T1 PPS 6X97.5MM TPRLC XR T1 PPS 16X152MM TPRLC XR FP TYPE1 PPS 6X132MM TPRLC XR MP T1 PPS 12X109MM TPRLC XR FP TYPE1 PPS 8X136MM TPRLC XR T1 PPS 13X146MM TPRLC XR MP T1 PPS 13X111MM TPRLC XR T1 PPS 14X148MM TPRLC XR MP FP T1 PPS 5X95MM TPRLC 133 FP TYPE1 PPS SO 4 TPRLC XR MP T1 PPS 11X107.5MM TPRLC XR FP TYPE1 PPS 4X128MM TPRLC 133 MP TYPE1 PPS HO 17 TPRLC XR MP T1 PPS 14X113MM TPRLC 133 FP TYPE1 PPS SO 15 Prostheisi, hip, hemi-, femoral, metal MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. EMPHASYS Femoral Stems VISTASEAL Dual Applicator DEPUY C-STEM SYSTEM CSTEM PFC Sigma APT PLI Insert DARWIN KNEE SYSTEM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 13MM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 9MM STD FEMORAL Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 9MM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 13MM STD FEMORAL Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 11MM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 15MM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 15MM STD FEMORAL Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 17MM Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 11MM STD FEMORAL Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 7MM STD FEMORAL Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 17MM STD FEMORAL VERSA-DIAL 38X19X39 HUM HEAD VERSA-DIAL 46X21X50 HUM HEAD VERSA-DIAL 50X21X57 HUM HEAD VERSA-DIAL 58X24X64 HUM HEAD VERSA-DIAL 42X18X46 HUM HEAD VERSA-DIAL 46X27X46 HUM HEAD VERSA-DIAL 50X27X50 HUM HEAD VERSA-DIAL 38X21X38 HUM HEAD VERSA-DIAL 46X18X53 HUM HEAD VERSA-DIAL 54X27X55 HUM HEAD VERSA-DIAL 54X21X64 HUM HEAD VERSA-DIAL 42X24X42 HUM HEAD VERSA-DIAL 58X27X61 HUM HEAD VERSA-DIAL 50X24X52 HUM HEAD VERSA-DIAL 42X21X43 HUM HEAD VERSA-DIAL 54X24X58 HUM HEAD VERSA-DIAL 46X24X47 HUM HEAD G7 Acetabular System Item # 010001038 G7 Acetabular System Item # 010001044 G7 Acetabular System Item # 010001035 G7 Acetabular System Item # 010001039 G7 Acetabular System Item # 010001033 G7 PPS LTD ACET SHELL 58G Item # 010000666 G7 PPS LTD ACET SHELL 46B Item # 010000660 G7 Acetabular System Item # 010001037 G7 Acetabular System Item # 010001036 G7 Acetabular System Item # 010001043 G7 Acetabular System Item # 010001034 G7 Acetabular System Item # 010001042 G7 Acetabular System Item # 010001031 G7 Acetabular System Item # 010001040 G7 Acetabular System Item # 010001032 G7 Acetabular System Item # 010001041 G7 PPS LTD ACET SHELL 42A Item # 010000658 G7 PPS LTD ACET SHELL 62H Item # 010000668 G7 PPS LTD ACET SHELL 44A Item # 010000659 G7 PPS LTD ACET SHELL 48C Item # 010000661 G7 PPS LTD ACET SHELL 50D Item # 010000662 G7 PPS LTD ACET SHELL 52E Item # 010000663 G7 PPS LTD ACET SHELL 56F Item # 010000665 G7 PPS LTD ACET SHELL 64H Item # 010000669 G7 PPS LTD ACET S HELL 66I Item # 010000670 G7 PPS LTD ACET SHELL 60G Item # 010000667 G7 PP S LTD ACET SHELL 54F Item # 010000664 G7 PPS LTD ACET SHELL 68I Item # 010000671 CATHETER CONNECTIONS' DUALCAP SOLO TITANIUM HIP 1019 COMP RVRS SHLDR GLNSP STD 41MM VERSA-DIAL/COMP TI STD TAPER COMP RVRS SHLDR GLNSP +6 36MM COMP RVRS SHLDR GLNSP +6 41MM COMP RVSR SHLDR GLNSP +3 36MM COMP RVSR SHLDR GLNSP +3 41MM COMP RVRS SHLDR GLNSP STD 36MM 25MM VERSA-DIAL TAPER ADAPTOR DePuy Actis Duofix Hip Prosthesis ALLEVYN Non Adhesive Allevyn Tracheostomy Delta Xtend Reverse Shoulder System Sion Surgical Instrument - sterile, single-use device MODULAR CATHCART FRACTURE SYSTEM Modular Cathcart Ball Pen Needle Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented ACTIS COLLARLESS SUMMIT ACETABULAR SYSTEM Expedium Spine System, VIPER and VIPER 2 systems DEPUY DURALOC 400 ACETABULAR CUP ARTICUL/EZE FOCUS TOTAL HIP SYSTEM J-FX BIPOLAR HEAD DURALOC OPTION ACETABULAR CUP SYSTEM FLUT TIB ROD P.F.C.* FLUT TIB ROD DARWIN KNEE SYSTEM (TC3) PFC SIGMA KNEE SYS PFC Mod. Tibial Tray Exoflow 3-in-1 Shaver, 5mm Curved Standard Shaver, 3.4mm Dynablator Standard Shaver, 3.4mm Standard Burr, 5mm 3-in-1 Shaver, 4.2mm Veriflow DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS LARGE FEMORAL IMPLANT Oxford PKS Cemented tibia, Alpha, Standard - RM Size B Oxford PKS Cemented tibia, Alpha, Standard - LM Size B Oxford PKS Cemented tibia, Alpha, Standard - LM Size C Oxford PKS Cemented tibia, Alpha, Standard - RM Size F Oxford PKS Cemented tibia, Alpha, Standard - LM Size D Oxford PKS Cemented tibia, Alpha, Standard - RM Size AA SMALL FEMORAL IMPLANT Oxford PKS Cemented tibia, Alpha, Standard - LM Size E MEDIUM FEMORAL IMPLANT Oxford PKS Cemented tibia, Alpha, Standard - LM Size A X-SMALL FEMORAL IMPLANT Oxford PKS Cemented tibia, Alpha, Standard - RM Size E Oxford PKS Cemented tibia, Alpha, Standard - RM Size D Oxford PKS Cemented tibia, Alpha, Standard - LM Size F Oxford PKS Cemented tibia, Alpha, Standard - RM Size C X-LARGE FEMORAL IMPLANT Oxford PKS Cemented tibia, Alpha, Standard - LM Size AA Oxford PKS Cemented tibia, Alpha, Standard - RM Size A C-Stem AMT LE Prosthesis Global Unite Platform Shoulder System GLOBAL UNITE Platform Shoulder System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-08-29
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-08-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-08-29
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-02-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-02-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-08-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-08-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-04-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-04-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-06-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-06-28
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-06-28
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2023-02-21
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2023-02-21
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2020-08-31
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-08-31
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-08-31
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-06-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-06-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-06-27
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2024-06-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-04
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-04-17
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-08-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-27
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2013-03-24
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-06-30
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2019-02-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-06-27
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-06-27
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-04-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-10-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2014-10-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-06-28
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-01-25
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-04-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2004-08-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-03-24
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2013-03-24
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-06-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-06-30
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-30
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2022-06-30
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2022-06-30
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2022-06-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-30
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2022-06-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2022-06-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-06-30
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2019-04-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-08-31
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-08-31
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-08-31
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-08-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-08-31
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-08-31
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-08-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-08-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-03-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-06-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-06-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2013-03-24
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-12-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-06-26
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2014-10-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-06-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-06-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-06-27
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2024-06-27
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2026-01-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-04
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-04-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-04-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-12-05
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2018-12-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-12-05
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2018-12-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-12-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-12-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-12-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-12-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2018-12-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-18
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2013-03-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-06-30
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2022-06-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2022-06-30
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-30
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-06-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-06-30
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2022-06-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-08-31
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2024-06-28
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2013-03-24
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-06-30
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-06-30
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-06-30
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2022-06-30
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-04-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-06-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-06-28
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-06-28
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-06-28
MZM	Fibrin Sealant Preparation Device	General Hospital	Class 2	880.5860	2019-06-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-02-21
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2023-02-21
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-02-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-02-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2023-02-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-02-21
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2023-02-21
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2023-02-21
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2023-02-21
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2023-02-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-02-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-06-30
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-06-30
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-06-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-06-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-14
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2022-03-05
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2022-03-05
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2022-03-05
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2022-03-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-03-05
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2022-03-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-03-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-03-05
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2014-10-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-06-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-06-30
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-06-27
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-06-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-04-15
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-28
KMC	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Orthopedic	Class 2	888.3340	2019-08-05
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2023-06-01
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2013-04-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-31
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-08-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-08-05
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-08-31
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-08-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-08-31
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-08-31
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-08-31
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-09-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-09-22
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-09-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-09-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-28
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2024-06-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-06-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-06-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-27
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-12-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-06-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-06-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-03-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-03-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-04-17
NRA	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2022-06-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-06-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-06-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-06-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-06-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Shen Business: MANTON BUSINESS & TECHNOLOGY SERVICES, LLC Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

SHANGHAI JPY ION-TECH CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004748528. Last updated year: 2026. Please use registration number 3004748528 when referencing this establishment in official correspondence.