The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for 36mm C-taper Femoral Head Components (lfit And Non-lfit).
Device ID | K021310 |
510k Number | K021310 |
Device Name: | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Jennifer A Daudelin |
Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | JDI |
Subsequent Product Code | KWY |
Subsequent Product Code | LWJ |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-25 |
Decision Date | 2002-05-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327072389 | K021310 | 000 |
07613327072372 | K021310 | 000 |
07613327072365 | K021310 | 000 |
07613327072358 | K021310 | 000 |