TM-400 DEVICE
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
Zimmer Trabecular Metal Technology, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005751028 | 3005751028 | Zimmer Trabecular Metal Technology, Inc. | 1 | N | 2026-01-01 | 10 POMEROY RD. Parsippany NJ US 07054 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3881 | 1421425663 | K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | JDI | 2000-03-01 |
| 3881 | 1885577698 | K982751 | IMPLEX SCREW AND WASHER SYSTEM | MBI | 1999-02-01 |
| 3881 | 1126790165 | K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | JDI | 1997-08-06 |
| 3881 | 1624360001 | K962468 | HEDROCEL ACETABULAR RESTRICTOR | JDI | 1997-02-03 |
| 3881 | 1585080687 | K915187 | CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW | HWC | 1991-12-19 |
| 3881 | 1083675185 | K230243 | ROSA® Knee System | OLO | 2023-03-29 |
| 3881 | 1812230988 | K221928 | ROSA® Knee System | OLO | 2022-10-04 |
| 3881 | 1009567224 | K210121 | ROSA Partial Knee System | OLO | 2021-04-19 |
| 3881 | 1292390348 | K191625 | Persona Revision Knee System | JWH | 2019-09-05 |
| 3881 | 1014947090 | K181947 | Persona Revision Knee System | JWH | 2018-10-25 |
| 3881 | 1941588720 | K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | MBH | 2012-06-29 |
| 3881 | 1423302653 | K111119 | TRABECULAR METAL (TM) FUSION DEVICE | ODP | 2011-11-23 |
| 3881 | 1013867002 | K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | MBH | 2011-02-15 |
| 3881 | 1828654717 | K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | MBH | 2010-12-13 |
| 3881 | 1638310661 | K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | KWS | 2007-06-29 |
| 3881 | 1594754629 | K070382 | VISTA -S DEVICE | MQP | 2007-05-30 |
| 3881 | 2025023603 | K061067 | TRABECULAR METAL ACETABULAR AUGMENTS | LPH | 2006-05-25 |
| 3881 | 1831606495 | K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | MBH | 2006-02-27 |
| 3881 | 1199615981 | K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | JWH | 2005-07-27 |
| 3881 | 1986789261 | K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS | LPH | 2005-05-11 |
| 3881 | 1838378968 | K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | HWE | 2005-05-26 |
| 3881 | 1422325305 | K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | HRS | 2005-04-15 |
| 3881 | 1766096355 | K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 | LPH | 2004-12-21 |
| 3881 | 1475184177 | K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | MBH | 2004-12-21 |
| 3881 | 1349138953 | K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | JWH | 2004-01-08 |
| 3881 | 2019840478 | K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | MQP | 2003-07-11 |
| 3881 | 1205203392 | K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | MBH | 2003-08-06 |
| 3881 | 1174508744 | K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS | JWH | 2003-01-15 |
| 3881 | 1344130432 | K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 | JWH | 2002-02-12 |
| 3881 | 1231872388 | K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | JWH | 2001-09-26 |
| 3881 | 1923929903 | K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | JWH | 2001-07-19 |
| 3881 | 1447519519 | K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY | JWH | 2001-01-25 |
| 3881 | 2044764488 | K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ | LPH | 2000-11-07 |
| 3881 | 1797051254 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | JDI | 2000-08-24 |
| 3881 | 1553985634 | ||||
| 3881 | 1644029891 | ||||
| 3881 | 1857052096 | ||||
| 3881 | 1006254678 | ||||
| 3881 | 1010382772 | ||||
| 3881 | 1066195091 | ||||
| 3881 | 1069335971 | ||||
| 3881 | 1073829315 | ||||
| 3881 | 1146220690 | ||||
| 3881 | 1163477802 | ||||
| 3881 | 1167770217 | ||||
| 3881 | 1201665297 | ||||
| 3881 | 1238532161 | ||||
| 3881 | 1263911200 | ||||
| 3881 | 1271045538 | ||||
| 3881 | 1273471294 | ||||
| 3881 | 1299384265 | ||||
| 3881 | 1310069538 | ||||
| 3881 | 1344833508 | ||||
| 3881 | 1379388912 | ||||
| 3881 | 1395240126 | ||||
| 3881 | 1396341290 | ||||
| 3881 | 1403097263 | ||||
| 3881 | 1414855037 | ||||
| 3881 | 1421774982 | ||||
| 3881 | 1429077568 | ||||
| 3881 | 1446387881 | ||||
| 3881 | 1494941052 | ||||
| 3881 | 1564280077 | ||||
| 3881 | 1571932724 | ||||
| 3881 | 1577612516 | ||||
| 3881 | 1595522920 | ||||
| 3881 | 1605122898 | ||||
| 3881 | 1646027497 | ||||
| 3881 | 1679317397 | ||||
| 3881 | 1686918717 | ||||
| 3881 | 1711730701 | ||||
| 3881 | 1723065765 | ||||
| 3881 | 1730113236 | ||||
| 3881 | 1741749231 | ||||
| 3881 | 1742370338 | ||||
| 3881 | 1824032562 | ||||
| 3881 | 1866461550 | ||||
| 3881 | 1872583522 | ||||
| 3881 | 1879888589 | ||||
| 3881 | 1899236421 | ||||
| 3881 | 1916744772 | ||||
| 3881 | 1926741233 | ||||
| 3881 | 1978989058 | ||||
| 3881 | 2007768347 | ||||
| 3881 | 2049974031 | ||||
| 3881 | 2072802714 |
Product Codes Associated With Registrations#
PMN#
TRABECULAR METAL FEMORAL CONE AUGMENTS
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.