TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
FDA 510(k) clearance K981529 · decided 1998-07-09
Clearance details
- K-number
- K981529
- Device name
- TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-29
- Decision date
- 1998-07-09
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JDS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON S recall (Z-0943-2013) | Smith & Nephew Inc | 2013-03-13 |
| INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON S recall (Z-0944-2013) | Smith & Nephew Inc | 2013-03-13 |
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|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
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| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
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