The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Pt Distal Tip Cement Spacer.
Device ID | K894708 |
510k Number | K894708 |
Device Name: | PT DISTAL TIP CEMENT SPACER |
Classification | Prosthesis, Hip, Cement Restrictor |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Pat Kramer |
Correspondent | Pat Kramer OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | JDK |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-24 |
Decision Date | 1989-10-10 |