The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Noiles Posterior Stabilized Total Knee System Ii.
| Device ID | K944321 |
| 510k Number | K944321 |
| Device Name: | S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Kevin J Crossen |
| Correspondent | Kevin J Crossen JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1995-08-14 |