The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Medium External Fixation System.
| Device ID | K011034 |
| 510k Number | K011034 |
| Device Name: | SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793957980 | K011034 | 000 |
| H6793957970 | K011034 | 000 |
| H6793957960 | K011034 | 000 |
| H6793957920 | K011034 | 000 |
| H6793957880 | K011034 | 000 |
| H6793957860 | K011034 | 000 |
| H6793957840 | K011034 | 000 |
| H6793957820 | K011034 | 000 |
| H6793957790 | K011034 | 000 |