Zimmer Trabecular
Allendale, NJ, US
Zimmer Trabecular appears in FDA device records in Allendale, NJ. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Zimmer Trabecular between 2004 and 2006. The busiest year on record is 2005, with 5. The most recent is 2006, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061155 | VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | Substantially Equivalent | |
| K061067 | TRABECULAR METAL ACETABULAR AUGMENTS | LPH | Substantially Equivalent | |
| K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | MBH | Substantially Equivalent | |
| K052950 | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | Substantially Equivalent | |
| K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | JWH | Substantially Equivalent | |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | HWE | Substantially Equivalent | |
| K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS | LPH | Substantially Equivalent | |
| K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | HRS | Substantially Equivalent | |
| K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 | LPH | Substantially Equivalent | |
| K043061 | THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX | KWS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HRSPlate, Fixation, Bone
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MQPSpinal Vertebral Body Replacement Device
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain