SYNTHES (USA) TIBIAL NAIL SYSTEM EX
FDA 510(k) clearance K040762 · decided 2004-04-12
Clearance details
- K-number
- K040762
- Device name
- SYNTHES (USA) TIBIAL NAIL SYSTEM EX
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2004-03-25
- Decision date
- 2004-04-12
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- JDS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Sy recall (Z-2051-2015) | Synthes, Inc. | 2015-07-08 |
| Synthes Trauma Nail System. The devices are indication for bone fixation. recall (Z-2058-2013) | Synthes USA HQ, Inc. | 2013-08-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |