The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5 Mm Low Profile Pelvic Reconstruction Plate.
| Device ID | K031573 |
| 510k Number | K031573 |
| Device Name: | SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-20 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792459160 | K031573 | 000 |
| H6792450350 | K031573 | 000 |
| H6792450340 | K031573 | 000 |
| H6792450330 | K031573 | 000 |
| H6792450320 | K031573 | 000 |
| H6792450310 | K031573 | 000 |
| H6792450300 | K031573 | 000 |
| H6792450290 | K031573 | 000 |
| H6792450280 | K031573 | 000 |
| H6792450270 | K031573 | 000 |
| H6792450260 | K031573 | 000 |
| H6792450250 | K031573 | 000 |
| H6792450240 | K031573 | 000 |
| H6792450360 | K031573 | 000 |
| H6792450380 | K031573 | 000 |
| H6792459140 | K031573 | 000 |
| H6792459120 | K031573 | 000 |
| H6792459100 | K031573 | 000 |
| H6792459080 | K031573 | 000 |
| H6792459060 | K031573 | 000 |
| H6792458860 | K031573 | 000 |
| H6792458840 | K031573 | 000 |
| H6792458820 | K031573 | 000 |
| H6792458800 | K031573 | 000 |
| H6792458780 | K031573 | 000 |
| H6792458760 | K031573 | 000 |
| H6792450390 | K031573 | 000 |
| H6792450230 | K031573 | 000 |