The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom/noiles Mark 3.
| Device ID | K896048 |
| 510k Number | K896048 |
| Device Name: | S-ROM/NOILES MARK 3 |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| 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 | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1990-03-14 |