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 |