The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anatomical Locking Plate System.
| Device ID | K961413 |
| 510k Number | K961413 |
| Device Name: | SYNTHES ANATOMICAL LOCKING PLATE SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792926990 | K961413 | 000 |
| H6794223450 | K961413 | 000 |
| H6794223440 | K961413 | 000 |
| H6794223410 | K961413 | 000 |
| H6794223400 | K961413 | 000 |
| H6794223090 | K961413 | 000 |
| H6794223080 | K961413 | 000 |
| H6794223050 | K961413 | 000 |
| H6794223040 | K961413 | 000 |
| H6794223010 | K961413 | 000 |
| H6794223480 | K961413 | 000 |
| H6794223490 | K961413 | 000 |
| H6794223900 | K961413 | 000 |
| H6794224040 | K961413 | 000 |
| H6794224020 | K961413 | 000 |
| H6794223970 | K961413 | 000 |
| H6794223960 | K961413 | 000 |
| H6794223950 | K961413 | 000 |
| H6794223940 | K961413 | 000 |
| H6794223930 | K961413 | 000 |
| H6794223920 | K961413 | 000 |
| H6794223910 | K961413 | 000 |
| H6794223000 | K961413 | 000 |