The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Lcp Hook Plate.
| Device ID | K082072 |
| 510k Number | K082072 |
| Device Name: | SYNTHES (USA) 3.5MM LCP HOOK PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-22 |
| Decision Date | 2008-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902113103S0 | K082072 | 000 |
| H679021131030 | K082072 | 000 |
| H67904113103S0 | K082072 | 000 |
| H679041131030 | K082072 | 000 |