The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Noiles Total Knee Prosthesis.
Device ID | K870730 |
510k Number | K870730 |
Device Name: | NOILES TOTAL KNEE PROSTHESIS |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Contact | Douglas G Noiles |
Correspondent | Douglas G Noiles 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 | 1987-02-25 |
Decision Date | 1987-05-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295179856 | K870730 | 000 |
10603295179764 | K870730 | 000 |
10603295179771 | K870730 | 000 |
10603295179788 | K870730 | 000 |
10603295179795 | K870730 | 000 |
10603295179801 | K870730 | 000 |
10603295179818 | K870730 | 000 |
10603295179825 | K870730 | 000 |
10603295179832 | K870730 | 000 |
10603295179849 | K870730 | 000 |
10603295179757 | K870730 | 000 |