510(k) K071481

HEALIX ANCHOR by Depuy Mitek, A Johnson & Johnson Company — Product Code HWC

K071481 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "HEALIX ANCHOR". The FDA issued a decision of Substantially Equivalent on Aug 9, 2007. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 9, 2007
Date Received
May 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K071481. Report a data issue: hello@regdatalab.com.