The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Univ Spine Rod/sacral Screw Fix Syst.
| Device ID | K930891 |
| 510k Number | K930891 |
| Device Name: | SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane C Tiernan |
| Correspondent | Diane C Tiernan SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1994-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814985250 | K930891 | 000 |