The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.4 Mm Cannulated Compression Screw.
| Device ID | K021556 |
| 510k Number | K021556 |
| Device Name: | SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-13 |
| Decision Date | 2002-08-09 |
| Summary: | summary |