The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Imf Screws.
| Device ID | K010527 |
| 510k Number | K010527 |
| Device Name: | SYNTHES (USA) IMF SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9802019320 | K010527 | 000 |
| H9802019280 | K010527 | 000 |
| H980201932E0 | K010527 | 000 |
| H980201928E0 | K010527 | 000 |
| H980SD2019300 | K010527 | 000 |