The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Healix Advance Peek Anchor.
Device ID | K120449 |
510k Number | K120449 |
Device Name: | HEALIX ADVANCE PEEK ANCHOR |
Classification | Screw, Fixation, Bone |
Applicant | Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
Contact | Yayoi Fujimaki |
Correspondent | Yayoi Fujimaki Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-14 |
Decision Date | 2012-05-11 |
Summary: | summary |