Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681465

FEI Number

3002807113

Entity Name

Gammatom S.r.l.

City/State/Country

GUANZATE (CO) Como, IT

Establishment Address

VIA XXIV MAGGIO, 14, GUANZATE (CO) Como 22070, IT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

GAMMATOM Srl (Owner Number: 9023536)

Owner / Operator Contact Address

VIA XXIV MAGGIO, 14, --, GUANZATE, IT-CO 22070, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CMD 24-1060 ProMade Elbow CMD 23-1434 ProMade Elbow CMD 24-1099 ProMade Elbow CMD 25-1263 ProMade ELbow CMD 25-1026 ProMade ELbow MPACT EXTENSION MOTO Partial Knee System & MOTO PFJ SMR REVERSE SHOULDER SYSTEM ENDO HEAD GMK TOTAL KNEE SYSTEM MPACT DM LINER CONVERTER Quadra-P Medacta Shoulder System MUST LT + MUST Extension GMK SPHERE CMD 25-1115 ProMade Elbow CMD 24-1623 ProMade Elbow CMD 25-1142 ProMade Elbow CMD 25-1082 ProMade Elbow CMD 25-1264 ProMade Elbow CMD 25-1245 ProMade Elbow CMD 24-1416 ProMade Elbow CMD 24-1613 ProMade Elbow CMD 25-1076 ProMade Elbow CMD 23-1428 ProMade Elbow CMD 24-1029 ProMade Elbow CMD 25-1406 ProMade Elbow CMD 24-1524 ProMade Elbow CMD 24-1186 ProMade Elbow CMD 24-1157 ProMade Elbow CMD 24-1503 ProMade Elbow CMD 25-1128 ProMade Elbow CMD 25-1324 ProMade Elbow CMD 24-1059 ProMade Elbow SYNTHECEL Dura Repair 7,5x7,5 cm SYNTHECEL Dura Repair 10x12 cm SYNTHECEL Dura Repair 2,5x7,5 cm SYNTHECEL Dura Repair 5x5 cm SYNTHECEL Dura Repair 2,5x2,5 cm SYNTHECEL Dura Repair 14x20 cm GMK REVISION EXTENSION AMISteam-C Extension size 00 VERSAFITCUP CC TRIO Shoulder Long Stem MOTO PFJ System SMR 140° Reverse Humeral Body M.U.S.T. MINI Posterior Cervical Screws System GMK Revision and Hinge - TiNbN SAM CRRT Unit SAM Cassette CRRT MOTO Partial Knee System GMK SHORT STEM MYSPINE PEDICLE SCREW PLACEMENT GUIDES BD BBL CultureSwab MaxV Plus Copan Venturi Transystem Amies Medium with Charcoal BD BBL CultureSwab BD BBL CultureSwab Plus HealthLink Transporter Copan M40 Transystem META-C CERVICAL PLATE Mpact® 3D Metal Implants and Augments 3D Metal MiniMax - Cementless anatomical stems size 9 Lateralized Glenosphere MectaLIF Anterior Stand Alone Extension AMIS-K Long MECTACER BIOLOX FORTE-FEMORAL HEADS VERSAFIT CUP DOUBLE MOBILITY SYSTEM Shoulder SensiTiN SMR Hybrid Glenoid System MectaLIF Anterior Stand-Alone MUST Mini Extension PRIMA TT Glenoid M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System BD Inoculation Loops Disposable Transfer Pipettes GMK HINGE BC+ Dry Swab Tube NextAR TKA Platform Humeral Eccentric Reverse metaphysis MasterLoc Stem: Lateralized Plus SMS Stem sizes 1-2-14-15 TEMA Elbow system - Line extension TearRepair Liquid Skin Protectant Bone Screw Revision Bone Screw Locking Bone Screw SMR 40MM GLENOSPHERE SMR TT METAL BACK GLENOID BD BBL CultureSwab MaxV Plus HealthLink Transporter BD BBL CultureSwab Plus Copan M40 Transystem BD BBL CultureSwab Copan Venturi Transystem Amies Medium With Charcoal SMR Shoulder System SMS collared AMISteam-P Short Neck MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H QUADRA H QUADRA S SMR Stemless Anatomic PVC - Free Empty IV Mixing Container Copan Venturi Transystem Liquid Amies Medium BD BBL CultureSwab MaxV HealthLink Transporter BD BBL CultureSwab M-ARS ACL: Anatomic Ribbon Surgery System Copan Liquid Amies ESwab BD ESwab PHYSICA KR KNEE SYSTEM AMF TT Cones MySpine Extension Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Copan Easy-Swab Collection and Transport System BD BBL CultureSwab EZ M-Vizion Femoral Revision System Extension M.U.S.T. Combined Set Screws SMR Shoulder System MPACT EXTENSION Delta Dual Mobility System Delta Multihole TT Pro Acetabular System BD BBL CultureSwab Copan Venturi Transystem Cary-Blair Medium SMR TT Augmented Glenoid System M.U.S.T. MC Cross Connector FasTip Copan Venturi Transystem Amies Medium Without Charcoal BD BBL CultureSwab MaxV Plus HealthLink Transporter BD BBL CultureSwab Plus BD BBL CultureSwab Copan M40 Transystem GMK Revision Femoral Distal Augmentation MECTALIF TRANSFORAMINAL MectaLIF Extension M.U.S.T. MINI Posterior Cervical Screws System GMK - LINE EXTENSION MECTALIF ANTERIOR Elos Intramedullary Nailing System MySpine Pedicle Screw Placement Guides - LP DIMI RRT System GMK Hinge GMK Revision MECTA-C Delta TT Pro VERSAFITCUP CC TRIO EXTENSION MectaLIF Anterior 3DMetal Tibial Cones Ligament staple MasterLoc Stem PAO Cortical Screw SMR Shoulder System Glenoid Polyaxial Non-locking Screw SYNTHECEL Dura Repair 7,5x7,5 cm SYNTHECEL Dura Repair 2,5x7,5 cm SYNTHECEL Dura Repair 5x5 cm SYNTHECEL Dura Repair 2,5x2,5 cm SYNTHECEL Dura Repair 10x12 cm M.U.S.T. Pedicle Screw System Medacta Shoulder System Short Humeral Diaphysis MECTACER BIOLOX OPTION HEADS M.U.S.T PEDICLE SCREW SYSTEM Protection Sleeve & Trocar MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments AMF TT Cones EVOLIS TOTAL KNEE SYSTEM M-Vizion Femoral Revision System Monobloc Polyester Fiber Swab, Sterile Cotton Fiber Swab, Sterile Nylon Fiber Swab, Sterile Rayon Fiber Swab, Sterile CLASSIQSwab GMK NARROW M.U.S.T. EXTENSION MectaLIF Posterior Extension BD BBL CultureSwab HealthLink Transporter BD BBL CultureSwab MaxV Copan Venturi Transystem Stuarts Medium MySpine Guides Physica system GMK Sphere Revision Medacta Anatomic Shoulder Prosthesis Mecta-C TiPEEK GMK EXTENSION InterSpace GV Hip Tapered Wedge stem CMD 24-1491 ProMade Hip CMD 24-1586 ProMade Hip CMD 24-1441 ProMade Hip CMD 24-1439 ProMade Hip CMD 24-1417 ProMade Hip CMD 24-1336 ProMade Hip CMD 24-1137 ProMade Hip CMD 24-1396 ProMade Hip CMD 24-1278 ProMade Hip CMD 24-1454 ProMade Hip CMD 24-1434 ProMade Hip CMD 24-1494 ProMade Hip CMD 24-1568 ProMade Hip CMD 24-1298 ProMade Hip MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT MectaLIF Anterior Stand Alone Mpact Double Mobility System BD BBL CultureSwab Cepheid Liquid Stuart Venturi Transystem Copan Venturi Transystem Stuarts Medium HealthLink Transporter BD BBL CultureSwab MaxV Copan Venturi Transystem Liquid Stuarts Medium CultureSwab ALLIGENCE GMK 3D Metal Tibial Tray MECTALIF TIPEEK MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK MySpine S2-AlarAlar-Iliac Pedicle Screws Placement Guides CMD 25-1223 ProMade Shoulder CMD 24-1326 ProMade Shoulder CMD 25-1164 ProMade Shoulder CMD 25-1136 ProMade Shoulder CMD 25-1274 ProMade Shoulder CMD 25-1038 ProMade Shoulder CMD 25-1163 ProMade Shoulder CMD 24-1592 ProMade Shoulder CMD 24-1423 ProMade Shoulder CMD 24-1556 ProMade Shoulder CMD 24-1616 ProMade Shoulder CMD 24-1410 ProMade Shoulder CMD 24-1362 ProMade Shoulder CMD 25-1260 ProMade Shoulder CMD 24-1463 ProMade Shoulder CMD 25-1435 ProMade Shoulder CMD 24-1620 ProMade Shoulder CMD 25-1459 ProMade Shoulder CMD 24-1457 ProMade Shoulder CMD 25-1176 ProMade Shoulder CMD 24-1655 ProMade Shoulder CMD 25-1079 ProMade Shoulder CMD 24-1365 ProMade Shoulder CMD 24-1486 ProMade Shoulder CMD 25-1411 ProMade Shoulder CMD 24-1456 ProMade Shoulder CMD 24-1429 ProMade Shoulder CMD 24-1380 ProMade Shoulder CMD 24-1481 ProMade Shoulder CMD 25-1436 ProMade Shoulder CMD 25-1217 ProMade Shoulder CMD 25-1233 ProMade Shoulder CMD 25-1444 ProMade Shoulder CMD 24-1629 ProMade Shoulder CMD 24-1375 ProMade Shoulder CMD 25-1151 ProMade Shoulder CMD 25-1138 ProMade Shoulder CMD 24-1446 ProMade Shoulder CMD 24-1542 ProMade Shoulder CMD 24-1224 ProMade Shoulder CMD 25-1460 ProMade Shoulder CMD 24-1562 ProMade Shoulder CMD 24-1263 ProMade Shoulder CMD 24-1470 ProMade Shoulder CMD 25-1248 ProMade Shoulder CMD 25-1110 ProMade Shoulder CMD 25-1253 ProMade Shoulder CMD 24-1405 ProMade Shoulder CMD 25-1336 ProMade Shoulder CMD 25-1071 ProMade Shoulder CMD 24-1422 ProMade Shoulder CMD 24-1509 ProMade Shoulder CMD 25-1024 ProMade Shoulder CMD 24-1347 ProMade Shoulder CMD 25-1042 ProMade Shoulder CMD 24-1327 ProMade Shoulder CMD 25-1369 ProMade Shoulder CMD 25-1111 ProMade Shoulder CMD 24-1240 ProMade Shoulder CMD 24-1132 Promade Shoulder CMD 25-1165 ProMade Shoulder CMD 24-1639 ProMade Shoulder Mecta-C Stand Alone Extension Kite Distal Fibula Kit MECTALIF SMS EcoFLX Empty Mixing Container MUST SI Headless extension M.U.S.T. MINI Posterior Cervical Screw System - OC SpheriKa TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT VCFix Spinal System Mpact 3D Metal DMLS Copan Venturi Transystem Amies Medium without Charcoal BD BBL CultureSwab Plus BD BBL CultureSwab MaxV Plus HealthLink Transporter Copan M40 Transystem BD BBL CultureSwab NextAR Spine Platform GMK SPHERE e-cross SMR Shoulder System MPACT ACETABULAR SYSTEM MasterLoc Stem MINIMA S SYSTEM Bone Screws dia. 50 mm BondEase 2 Topical Skin Adhesive GMK SPHERE EXTENSION FairFix Adjustable Button System - Round buttons MasterLoc Stem - Sizes 13 and 14 SYNTHECEL Dura Repair 10x12 cm SYNTHECEL Dura Repair 2,5x2,5 cm SYNTHECEL Dura Repair 2,5x7,5 cm SYNTHECEL Dura Repair 7,5x7,5 cm SYNTHECEL Dura Repair 5x5 cm SYSTEM, FACET CREW SPINAL DEVICE MectaScrew C NextAR RSA Platform M.U.S.T. SI screw and pelvic trauma system MyKnee PPS-Pin Positioners Femoral Component Quadra-P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIX	Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis	Unknown	Class N	N/A	2024-12-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2022-11-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2018-10-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-12-12
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-10-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-09-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-12-11
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-02-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-12-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2020-12-18
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-01-19
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2018-10-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-09-16
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-05-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2018-10-26
JDK	Prosthesis, Hip, Cement Restrictor	General, Plastic Surgery	Class 2	878.3300	2017-07-03
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2017-07-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-07-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-10-26
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2018-10-29
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-10-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-12-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-12-18
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-02-14
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2019-12-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-11-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-10-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-09-16
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2021-09-16
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-02-14
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-01-19
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2018-10-26
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-12-12
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2018-10-26
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2018-10-29
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2022-11-21
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2021-09-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-14
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	Class 2	888.3060	2023-02-14
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-03
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	Class 2	888.3060	2023-02-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-06-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-12-18
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2024-01-19
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-01-19
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2025-06-11
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2026-02-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2026-02-20
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-01-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-09-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2024-01-19
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2018-05-31
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-10-26
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2018-10-29
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2018-10-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-01-19
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2024-01-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-12-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-12-12
PQC	Pedicle Screw Placement Guide	Orthopedic	Class 2	888.3070	2021-09-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-10-26
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2019-12-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-02-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-09-16
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-09-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-10-26
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-10-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-01-19
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-01-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-01-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-01-19
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-01-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-01-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-01-19
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-12-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-02-18
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2018-10-26
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2018-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-11-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-11-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-07-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-10-26
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-05-19
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2018-10-26
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-10-26
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-01-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-01-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-02-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-09-16
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2020-06-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-09-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-14
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-12-12
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-02-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-10-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-10-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-10-26
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-10-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-07-03
PQC	Pedicle Screw Placement Guide	Orthopedic	Class 2	888.3070	2018-10-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-01-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-01-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-11-21
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-09-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-10-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-12
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
QSR	Sacroiliac Screw Placement Guide	Orthopedic	Class 2	888.3040	2022-11-21
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2026-02-20
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2026-02-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-02-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-09-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-10-26
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2017-07-03
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-07-03
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-02-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-10-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-02-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-14
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-03
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-02-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2026-02-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2026-02-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2026-02-18
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2024-12-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-06-18
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2020-06-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-10-26
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-11-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
PQC	Pedicle Screw Placement Guide	Orthopedic	Class 2	888.3070	2021-09-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-09-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-07-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-01
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-07-01
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-12-12
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2019-12-12
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2021-09-16
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2019-12-12
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-09-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-10-26
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2026-02-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-11-21
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-10-29
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2022-11-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-09-16
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2024-01-19
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2017-07-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-10-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2024-01-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-01-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-01-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-01-19
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-01-19
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-01-19
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-02-14
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-01-19
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-01-19
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2024-01-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-01-19
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2023-02-14
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2026-02-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-12-12
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2021-06-03
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-02-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-11-21
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-07-03
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2017-07-03
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2022-11-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-14
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2020-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-10-26
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-04-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-12-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-06-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-06-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-02-14

Official Correspondent

Andrea Soldini

US Agent Details

Stephen H. Lieberman Business: Donawa Consulting LLC Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

GAMMATOM Srl

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

Similar Registrations

Registration Number	Establishment Name	Location
3021386586	LINCOTEK (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3005562917	BGS Beta-Gamma-Service GmbH & Co KG	Bruchsal Baden-Wurttemberg, DE
1450662	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681465. Last updated year: 2026. Please use registration number 9681465 when referencing this establishment in official correspondence.