The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) External Fixation Component Line Extension - Mr Safe.
| Device ID | K043039 |
| 510k Number | K043039 |
| Device Name: | SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2005-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793956930 | K043039 | 000 |
| H6793900270 | K043039 | 000 |
| H6793900280 | K043039 | 000 |
| H6793947910 | K043039 | 000 |
| H6793947920 | K043039 | 000 |
| H6793947930 | K043039 | 000 |
| H6793956900 | K043039 | 000 |
| H6793956910 | K043039 | 000 |
| H6793900090 | K043039 | 000 |
| H6793900100 | K043039 | 000 |
| H6793900120 | K043039 | 000 |
| H6793900130 | K043039 | 000 |
| H6793900260 | K043039 | 000 |
| H6793900290 | K043039 | 000 |
| H6793900300 | K043039 | 000 |
| H6793956920 | K043039 | 000 |
| H6793900110 | K043039 | 000 |