The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Prosthesis System.
Device ID | K862837 |
510k Number | K862837 |
Device Name: | OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, 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 | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-25 |
Decision Date | 1986-12-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327033939 | K862837 | 000 |
07613327033922 | K862837 | 000 |