The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Co. with the FDA for Healix Ti Anchor.
Device ID | K082282 |
510k Number | K082282 |
Device Name: | HEALIX TI ANCHOR |
Classification | Screw, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham, MA 02767 |
Contact | Kristine Christo |
Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON CO. 325 Paramount Drive Raynham, MA 02767 |
Product Code | HWC |
Subsequent Product Code | JDR |
Subsequent Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-11 |
Decision Date | 2008-11-07 |
Summary: | summary |