The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile Drill Bits.
| Device ID | K962913 |
| 510k Number | K962913 |
| Device Name: | SYNTHES STERILE DRILL BITS |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HWE |
| Subsequent Product Code | GFA |
| Subsequent Product Code | GFF |
| Subsequent Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-26 |
| Decision Date | 1996-11-14 |
| Summary: | summary |