The following data is part of a premarket notification filed by Tornier with the FDA for Tornier, Piton Fixation Implant System.
Device ID | K091870 |
510k Number | K091870 |
Device Name: | TORNIER, PITON FIXATION IMPLANT SYSTEM |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | TORNIER 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
Contact | Howard L Schrayer |
Correspondent | Howard L Schrayer TORNIER 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-23 |
Decision Date | 2009-09-21 |
Summary: | summary |