The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Bone Augmentation Wedges.
Device ID | K874635 |
510k Number | K874635 |
Device Name: | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Dennis H Crane |
Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-10 |
Decision Date | 1988-03-10 |