The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Ostroncs Hemi-hip Stem Series.
Device ID | K922146 |
510k Number | K922146 |
Device Name: | OSTRONCS HEMI-HIP STEM SERIES |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Robert A Koch |
Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-07 |
Decision Date | 1992-08-11 |