The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Knee Jt. Patello Femoro Tibial Polymer/metal/polym.
Device ID | K922824 |
510k Number | K922824 |
Device Name: | KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM |
Classification | Prosthesis, Knee, Femorotibial, Non-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 | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-11 |
Decision Date | 1992-09-17 |