The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Reconstructive Plates 'y' Plates.
| Device ID | K792291 |
| 510k Number | K792291 |
| Device Name: | SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-13 |
| Decision Date | 1979-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679445000 | K792291 | 000 |
| H679245010 | K792291 | 000 |
| H679245020 | K792291 | 000 |
| H679245030 | K792291 | 000 |
| H679245040 | K792291 | 000 |
| H679245050 | K792291 | 000 |
| H679245060 | K792291 | 000 |
| H679245080 | K792291 | 000 |
| H679245100 | K792291 | 000 |
| H679245120 | K792291 | 000 |
| H679245140 | K792291 | 000 |
| H679245150 | K792291 | 000 |
| H679245000 | K792291 | 000 |
| H679229440 | K792291 | 000 |
| H679229330 | K792291 | 000 |
| H679229340 | K792291 | 000 |
| H679229350 | K792291 | 000 |
| H679229360 | K792291 | 000 |
| H679229370 | K792291 | 000 |
| H679229380 | K792291 | 000 |
| H679229390 | K792291 | 000 |
| H679229400 | K792291 | 000 |
| H679229410 | K792291 | 000 |
| H679229420 | K792291 | 000 |
| H679229430 | K792291 | 000 |
| H679245160 | K792291 | 000 |
| H679245170 | K792291 | 000 |
| H679245350 | K792291 | 000 |
| H679245360 | K792291 | 000 |
| H679445150 | K792291 | 000 |
| H679445160 | K792291 | 000 |
| H679445170 | K792291 | 000 |
| H679445180 | K792291 | 000 |
| H679445190 | K792291 | 000 |
| H679445010 | K792291 | 000 |
| H679245260 | K792291 | 000 |
| H679245280 | K792291 | 000 |
| H679245290 | K792291 | 000 |
| H679245340 | K792291 | 000 |
| H679245330 | K792291 | 000 |
| H679245180 | K792291 | 000 |
| H679245190 | K792291 | 000 |
| H679245200 | K792291 | 000 |
| H679245210 | K792291 | 000 |
| H679245220 | K792291 | 000 |
| H679245230 | K792291 | 000 |
| H679245240 | K792291 | 000 |
| H679245250 | K792291 | 000 |
| H679245300 | K792291 | 000 |
| H679245310 | K792291 | 000 |
| H679245320 | K792291 | 000 |
| H679245270 | K792291 | 000 |