The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Noiles(tm) Total Knee Prosthesis, Modification.
| Device ID | K905810 |
| 510k Number | K905810 |
| Device Name: | NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-26 |
| Decision Date | 1991-06-12 |