The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Cement Restrictor.
Device ID | K001932 |
510k Number | K001932 |
Device Name: | TORNIER CEMENT RESTRICTOR |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Contact | David W Schlerf |
Correspondent | David W Schlerf TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-26 |
Decision Date | 2000-07-20 |