Product code JDN
- Device name
- Implant, Fixation Device, Spinal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3060
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954856 | CANNULATED FEMORAL NAIL | Synthes (Usa) | 1996-03-08 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982231635 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982233233 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982233219 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982233172 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982233097 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231833 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231819 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231796 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231772 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231758 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231734 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231710 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231697 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231673 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231659 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231338 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231611 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231598 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231574 | NA | Synthes GmbH | 2015-09-14 |
| 10886982231550 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231536 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231512 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231499 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231475 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231451 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231437 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231413 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231390 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231376 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982231352 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |