The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Porous Polyethylene Implants.
| Device ID | K051879 |
| 510k Number | K051879 |
| Device Name: | SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS |
| Classification | Mesh, Surgical |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | FTM |
| Subsequent Product Code | FTL |
| Subsequent Product Code | GWO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98008520231S0 | K051879 | 000 |
| H98008510545S0 | K051879 | 000 |
| H98008510544S0 | K051879 | 000 |
| H98008510543S0 | K051879 | 000 |
| H98008510542S0 | K051879 | 000 |
| H98008510541S0 | K051879 | 000 |
| H98008510540S0 | K051879 | 000 |
| H98008510220S0 | K051879 | 000 |
| H98008510140S0 | K051879 | 000 |
| H98008510130S0 | K051879 | 000 |
| H98008510120S0 | K051879 | 000 |
| H98008510546S0 | K051879 | 000 |
| H98008510547S0 | K051879 | 000 |
| H98008510640S0 | K051879 | 000 |
| H98008520230S0 | K051879 | 000 |
| H98008520221S0 | K051879 | 000 |
| H98008520220S0 | K051879 | 000 |
| H98008520131S0 | K051879 | 000 |
| H98008520130S0 | K051879 | 000 |
| H98008520121S0 | K051879 | 000 |
| H98008520120S0 | K051879 | 000 |
| H98008510646S0 | K051879 | 000 |
| H98008510642S0 | K051879 | 000 |
| H98008510641S0 | K051879 | 000 |
| H98008510110S0 | K051879 | 000 |