The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Accolade C Femoral Stems.
Device ID | K022555 |
510k Number | K022555 |
Device Name: | ACCOLADE C FEMORAL STEMS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Debra Bing |
Correspondent | Debra Bing HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-02 |
Decision Date | 2002-08-26 |
Summary: | summary |