The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Precision Osteolock Femoral Comp. Titanium Plasma.
Device ID | K896853 |
510k Number | K896853 |
Device Name: | PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Mary C Spicer |
Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-05 |
Decision Date | 1990-05-02 |