The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Mod. Femoral Com. & Cluster Patter Outer Shell.
Device ID | K894149 |
510k Number | K894149 |
Device Name: | MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert Smith |
Correspondent | Robert Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-14 |
Decision Date | 1989-09-14 |