The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Calcaneal Plates.
| Device ID | K991407 |
| 510k Number | K991407 |
| Device Name: | SYNTHES LOCKING CALCANEAL PLATES |
| 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 | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 1999-04-22 |
| Decision Date | 1999-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792416270 | K991407 | 000 |
| H6792416260 | K991407 | 000 |
| H6792416250 | K991407 | 000 |
| H6792416240 | K991407 | 000 |
| H6792416230 | K991407 | 000 |
| H6792416220 | K991407 | 000 |
| H6792416190 | K991407 | 000 |
| H6792416180 | K991407 | 000 |