The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Ath-porous And Ath-porous Long Total Hip.
Device ID | K922421 |
510k Number | K922421 |
Device Name: | KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
Contact | Ian C Clark |
Correspondent | Ian C Clark KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-21 |
Decision Date | 1992-10-15 |