Synthes (Usa) · Class II · Cleared Mar 17, 1997
| K-number | K964416 |
| Device name | SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM |
| Applicant | Synthes (Usa) |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Mar 17, 1997 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 888.3060 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov