TRI-LOCK LONG STEM MODULAR NECK
FDA 510(k) clearance K864331 · decided 1987-01-06
Clearance details
- K-number
- K864331
- Device name
- TRI-LOCK LONG STEM MODULAR NECK
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-11-04
- Decision date
- 1987-01-06
- Days to decision
- 63 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |