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 |