The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom(tm) Femoral Stem Centralizer/cement Spacer.
Device ID | K904746 |
510k Number | K904746 |
Device Name: | S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER |
Classification | Prosthesis, Hip, Cement Restrictor |
Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Contact | Debra L Bing |
Correspondent | Debra L Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Product Code | JDK |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-18 |
Decision Date | 1990-11-20 |