CANNULATED FEMORAL NAIL
FDA 510(k) clearance K954856 · decided 1996-03-08
Clearance details
- K-number
- K954856
- Device name
- CANNULATED FEMORAL NAIL
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1995-10-23
- Decision date
- 1996-03-08
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- JDN
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (K897141) | Stuart | 1990-06-21 |
| BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM (K894184) | Biedermann Motech GmbH | 1990-04-25 |
| UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (K872715) | Roseburg SA | 1987-12-07 |
| NEW C-D SYSTEM FOR SPINAL SURGERY (K873977) | Sofamor Co. | 1987-12-07 |
| TOTAL SPINAL CORRECTION (K760649) | Depuy, Inc. | 1976-10-05 |
Recalls involving this device
No recalls on record reference this clearance.
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 |