The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Continuum Knee System.
Device ID | K920080 |
510k Number | K920080 |
Device Name: | CONTINUUM KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Contact | Richard W Cudworth |
Correspondent | Richard W Cudworth TECHMEDICA, INC. 3760 CALLE TECATE Camarillo, CA 93012 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-08 |
Decision Date | 1992-09-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CONTINUUM KNEE SYSTEM 75108890 2050944 Live/Registered |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. 1996-05-23 |
CONTINUUM KNEE SYSTEM 73756747 1577592 Dead/Cancelled |
TECHMEDICA, INC. 1988-10-11 |