The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modular Foot System - 2.7 Mm Module.
| Device ID | K010321 |
| 510k Number | K010321 |
| Device Name: | MODULAR FOOT SYSTEM - 2.7 MM MODULE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-02 |
| Decision Date | 2001-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792425360 | K010321 | 000 |
| H679242030 | K010321 | 000 |
| H6792029000 | K010321 | 000 |
| H6792028980 | K010321 | 000 |
| H6792028960 | K010321 | 000 |
| H6792028940 | K010321 | 000 |
| H6792028920 | K010321 | 000 |
| H6792028900 | K010321 | 000 |
| H6792028880 | K010321 | 000 |
| H6792028860 | K010321 | 000 |
| H6792028840 | K010321 | 000 |
| H6792028820 | K010321 | 000 |
| H6792028800 | K010321 | 000 |
| H6792028780 | K010321 | 000 |
| H6792028760 | K010321 | 000 |
| H6792028740 | K010321 | 000 |
| H6792028720 | K010321 | 000 |
| H679242040 | K010321 | 000 |
| H67924205070 | K010321 | 000 |
| H6792425350 | K010321 | 000 |
| H679242340 | K010321 | 000 |
| H679242320 | K010321 | 000 |
| H679242310 | K010321 | 000 |
| H6792422220 | K010321 | 000 |
| H6792422210 | K010321 | 000 |
| H6792422200 | K010321 | 000 |
| H6792422090 | K010321 | 000 |
| H6792422080 | K010321 | 000 |
| H6792422070 | K010321 | 000 |
| H6792422060 | K010321 | 000 |
| H6792422050 | K010321 | 000 |
| H6792422040 | K010321 | 000 |
| H679242080 | K010321 | 000 |
| H679242070 | K010321 | 000 |
| H679242060 | K010321 | 000 |
| H6792028700 | K010321 | 000 |