The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.4 Mm Universal Locking Plate System.
| Device ID | K961421 |
| 510k Number | K961421 |
| Device Name: | SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM |
| Classification | Plate, Bone |
| 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980497684E0 | K961421 | 000 |
| H9804496330 | K961421 | 000 |
| H9804496360 | K961421 | 000 |
| H9804496370 | K961421 | 000 |
| H9804496380 | K961421 | 000 |
| H9804496510 | K961421 | 000 |
| H9804496520 | K961421 | 000 |
| H9804496530 | K961421 | 000 |
| H9804496540 | K961421 | 000 |
| H9804496550 | K961421 | 000 |
| H980497668E0 | K961421 | 000 |
| H980497670E0 | K961421 | 000 |
| H980497672E0 | K961421 | 000 |
| H980497674E0 | K961421 | 000 |
| H980497676E0 | K961421 | 000 |
| H980497678E0 | K961421 | 000 |
| H980497680E0 | K961421 | 000 |
| H980497682E0 | K961421 | 000 |
| H9804496320 | K961421 | 000 |