The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinematic Iii Post Cruciate Total Condylar Knee Sy.
Device ID | K871772 |
510k Number | K871772 |
Device Name: | KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-06 |
Decision Date | 1987-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37613327589628 | K871772 | 000 |
37613327589611 | K871772 | 000 |
37613327589581 | K871772 | 000 |