The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Precision Osteolock Femoral Component.
Device ID | K944592 |
510k Number | K944592 |
Device Name: | PRECISION OSTEOLOCK FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-19 |
Decision Date | 1995-05-17 |