510(k) K954856
- Device
- CANNULATED FEMORAL NAIL
- Applicant
- SYNTHES (USA)
- 510(k) number
- K954856
- Product code
- JDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-08
- Date received
- 1995-10-23
- Regulation
- 888.3060
- Classification name
- Implant, Fixation Device, Spinal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANGELA J SILVESTRI
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3000270450
- 3010039400
- 1824199
- 3009417901
- 3011302692
- 3015212339
- 3018094310
- 1526439
- 1828464
- 3015399803
- 1030489
- 3005061536
- 3008812560
- 3008114965
- 1531174
- 2029275
- 3008868758
Source Documents#
Other 510(k) Records For Product Code JDN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | 1990-06-21 |
| K894184 | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Biedermann Motech GmbH | 1990-04-25 |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Roseburg SA | 1987-12-07 |
| K873977 | NEW C-D SYSTEM FOR SPINAL SURGERY | Sofamor Co. | 1987-12-07 |
| K760649 | TOTAL SPINAL CORRECTION | Depuy, Inc. | 1976-10-05 |
Legacy Summary#
summary
FDA Review#
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