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 |