The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Howmedica Osteonics Femoral Heads.
Device ID | K993601 |
510k Number | K993601 |
Device Name: | HOWMEDICA OSTEONICS FEMORAL HEADS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LWJ |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-25 |
Decision Date | 1999-11-16 |
Summary: | summary |