The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omniflex Normalized Hip Stem For Press-fit Fixat..
Device ID | K872768 |
510k Number | K872768 |
Device Name: | OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
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 | KWA |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-14 |
Decision Date | 1988-01-14 |