510(k) K071257

MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD by Depuy Mitek, A Johnson & Johnson Company — Product Code JDR

K071257 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD". The FDA issued a decision of Substantially Equivalent on Jun 29, 2007. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 29, 2007
Date Received
May 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K071257. Report a data issue: hello@regdatalab.com.