The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Accolade C Femoral Component.
Device ID | K002320 |
510k Number | K002320 |
Device Name: | ACCOLADE C FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
Contact | Nancy J Rieder |
Correspondent | Nancy J Rieder HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-31 |
Decision Date | 2000-09-14 |
Summary: | summary |