The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes External Fixation Devices, Mr Conditional.
| Device ID | K090658 |
| 510k Number | K090658 |
| Device Name: | SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Jill R Yelton |
| Correspondent | Jill R Yelton SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-12 |
| Decision Date | 2010-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793957810 | K090658 | 000 |