The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ha-coated Devices.
Device ID | K980070 |
510k Number | K980070 |
Device Name: | OSTEONICS HA-COATED DEVICES |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Terry Sheridan |
Correspondent | Terry Sheridan OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | MEH |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-08 |
Decision Date | 1999-07-23 |
Summary: | summary |