The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes(usa) Synthes Hybrid External Fixator.
| Device ID | K950384 |
| 510k Number | K950384 |
| Device Name: | SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679392180 | K950384 | 000 |
| H6793937460 | K950384 | 000 |
| H6793937450 | K950384 | 000 |