Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008102042

FEI Number

3002924544

Entity Name

Synergy Health Radeberg GMBH

City/State/Country

Radeberg Saxony, DE

Establishment Address

Juri-Gagarin-Strasse 15, Radeberg Saxony 01454, DE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Implantcast (RB) - AGILON XO Shoulder Replacement System BirrBio12027 (ED,RB) - ART Labware Implantcast (RB) - MK femoral spacer distal ll/rm incl. screw Implantcast (RB) - ACS® LD PS femoral component cemented Implantcast (RB) - screw for MK spacer Implantcast (RB) - ACS® LD FB+ Tibia cemented incl. plugs Implantcast (RB) - ACS® LD extension stem male taper Implantcast (RB) - MK femoral spacer posterior incl. screw Implantcast (RB) - ACS® stem Implantcast (RB) - ACS® LD femoral component cemented Implantcast (RB) - MK femoral spacer distal rl/lm incl. screw Implantcast (RB) - ACS® double taper Implantcast (RB) - ACS® FB screw for tibial spacer Implantcast (RB) - ACS® LD SC femoral component cemented Implantcast (RB) - ACS® FB tibial spacer lateral incl. screw DOT (RB) - Z1 Hip System DOT (RB) - Surgikor Dental Implant System Implantcast (RB) - ic-head CoCrMo 36 mm Implantcast (RB) - ic-head Bioloxdelta FirstWater14138 (RG,SE) - Medela Breast Pads (USA) FirstWater14138 (RG) - 73230-02 - Leukomed Control Sterile FirstWater14138 (RG) - 73230-03 - Leukomed Control Sterile FirstWater14138 (RG) - DUP86466-9 - Xtrasorb HCS Adhesive FirstWater14138 (RG) - Russell Chest Seal FirstWater14138 (RG) - DUP86322-9 Xtrasorb HCS FirstWater14138 (RG) - 73230-05 - Leukomed Control Sterile FirstWater14138 (RG) - CWL 1008 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1005 - KerraLite Cool FirstWater14138 (RG) - Curad Soothe & Cool Dressing (56 x 26mm) FirstWater14138 (RG) - CWL 1009 - KerraLite Cool Border FirstWater14138 (RG) - 6030-4156 - Glaciergel FirstWater14138 (RG) - CWL 1004 - KerraLite Cool FirstWater14138 (RG) - 73230-00 - Leukomed Control Sterile FirstWater14138 (RG) - CVS86433-9 Xtrasorb HCS Non- Adhesive 3""x3"" (cvs) FirstWater14138 (RG) - 40-2979 - Hydrogel Dressing FirstWater14138 (RG) - DUP86344 - Xtrasorb HCS 4.5" X 4.5" FirstWater14138 (RG) - DUP86388-9 - Xtrasorb HCS Non- Adhesive FirstWater14138 (RG) - 6030-4157 - Glaciergel FirstWater14138 (RG) - 73230-01 - Leukomed Control Sterile FirstWater14138 (RG) - Curad Soothe & Cool Dressing (74 x 45mm) FirstWater14138 (RG) - CWL 1007 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1006 - KerraLite Cool Implantcast (RB) - MUTARS® femoral stem cemented Implantcast (RB) - ACS LD Uni FB Knee System GattTech (RB) - ETHIZIA Hemostatic Patch Rover35148 (VL) - Rovers Anex Brush SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab Rover35148 (VL) - Rovers Evalyn Brush Medskin (RB) - MatriDerm pluS+ Bi-Layer Implantcast (RB) - Actinia® hip stems Implantcast (RB) - AGILON® XO Shoulder Replacement System MedSkin (RB) - MatriDerm DOT (RB) - Z1 Hip System SteriPack9541 (RB) - Celt ACD5F, Celt ACD6F, Celt ACD7F SteripacGmbH (RB) - Celt ACD®5F, Celt ACD®6F, Celt ACD®7F Newclip11561 (MS) - Soft tissues protector SteripackPoland (RB) - AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX Kuros12218 (RB) - MagnetOs Flex Matrix Implantcast (RB) - EcoFit® short stem cementless cpTi Implantcast (RB) - MUTARS femoral stem cemented BVI8325 (RG) - SPECULUM BLADED BVI8325 (RG) - LASIK CANNULA (DAYA) D.O.R.C. (VL1) - Backflush instrument DORC10527 (VL1) - Cannula, Ophthalmic CHMuller (RB) - Loop-X Disposable Sterile Drape Set Colplast1941 (RB) - SpeediCath Compact Female Colplast1941 (RB) - SpeediCath Compact Plus SteripackPoland (RB) - Mantis Spinal System DeSoutter8410 (DV) - Passing Pin DeSoutter8410 (DV,RG) - Stericut StrykerTrauma (RB) - Scalpel DORC10527 (VL1) - Forceps, Ophthalmic Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Implantcast (RB) - implaFit® Hip Stem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-09-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-28
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2024-01-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-11-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-09-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-12-03
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-12-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-12-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-12-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-12-05
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2019-04-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-04-11
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2013-03-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-06-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-06-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-12-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2022-09-28
FKQ	System, Dialysate Delivery, Central Multiple Patient	Gastroenterology, Urology	Class 2	876.5820	2017-09-21
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
SGV	Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	General, Plastic Surgery	Class 3	878.4490	2026-02-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-04-11
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-01-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-05-21
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-11-16
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-11-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-11-16
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-12-03
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-12-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-12-03
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2026-01-14
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-11-27
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2025-12-01
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-19
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-02-10
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-11-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-09-03
LRN	Wire, Surgical	Orthopedic	Class 2	888.3030	2016-11-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-10
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-04-06
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-12-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-12-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-06-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2019-04-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2019-12-03
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2023-12-12
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-11-12
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-11-25
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-04-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-06-23
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-12-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-03
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2025-12-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-09-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-09-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-09-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-06-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-18
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-12-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-06-17
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-05-26
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2026-01-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-26
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-11-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-06-23
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-06-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-06-23
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-12-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-12-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-12-02
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2016-11-18
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2016-11-12
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-10-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-10-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-10-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-11-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-09
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-02-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-06
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2019-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
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3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3011943495	PRECIMADE	Bourg en Bresse Ain, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008102042. Last updated year: 2026. Please use registration number 3008102042 when referencing this establishment in official correspondence.