The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinematic Ii Knee System.
Device ID | K823420 |
510k Number | K823420 |
Device Name: | KINEMATIC II KNEE SYSTEM |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-15 |
Decision Date | 1983-02-07 |