The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Cemented Ath-long Stem.
Device ID | K902073 |
510k Number | K902073 |
Device Name: | KINAMED CEMENTED ATH-LONG STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
Contact | Clarke, Phd |
Correspondent | Clarke, Phd KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-07 |
Decision Date | 1990-06-08 |