The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5 Mm Broad Lcp & 4.5 Mm Lcp Distal Humerus Plates.
| Device ID | K031178 |
| 510k Number | K031178 |
| Device Name: | SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902104034S0 | K031178 | 000 |
| H679021040080 | K031178 | 000 |
| H67902104006S0 | K031178 | 000 |
| H679021040060 | K031178 | 000 |
| H67902104004S0 | K031178 | 000 |
| H679021040040 | K031178 | 000 |
| H67904104034S0 | K031178 | 000 |
| H67904104032S0 | K031178 | 000 |
| H67904104030S0 | K031178 | 000 |
| H67904104028S0 | K031178 | 000 |
| H67904104026S0 | K031178 | 000 |
| H67904104024S0 | K031178 | 000 |
| H67904104014S0 | K031178 | 000 |
| H67904104012S0 | K031178 | 000 |
| H67904104010S0 | K031178 | 000 |
| H67904104008S0 | K031178 | 000 |
| H67904104006S0 | K031178 | 000 |
| H67902104008S0 | K031178 | 000 |
| H679021040100 | K031178 | 000 |
| H679021040340 | K031178 | 000 |
| H67902104032S0 | K031178 | 000 |
| H679021040320 | K031178 | 000 |
| H67902104030S0 | K031178 | 000 |
| H679021040300 | K031178 | 000 |
| H67902104028S0 | K031178 | 000 |
| H679021040280 | K031178 | 000 |
| H67902104026S0 | K031178 | 000 |
| H679021040260 | K031178 | 000 |
| H67902104024S0 | K031178 | 000 |
| H679021040240 | K031178 | 000 |
| H67902104014S0 | K031178 | 000 |
| H679021040140 | K031178 | 000 |
| H67902104012S0 | K031178 | 000 |
| H679021040120 | K031178 | 000 |
| H67902104010S0 | K031178 | 000 |
| H67904104004S0 | K031178 | 000 |