The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Elbow Hinge Fixator.
| Device ID | K063832 |
| 510k Number | K063832 |
| Device Name: | SYNTHES (USA) ELBOW HINGE FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Jennifer Perks |
| Correspondent | Jennifer Perks SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793940550 | K063832 | 000 |