510(k) K051989

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

K051989 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE". The FDA issued a decision of Substantially Equivalent on Aug 5, 2005. 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
Aug 5, 2005
Date Received
Jul 22, 2005
Clearance Type
Special
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 K051989. Report a data issue: hello@regdatalab.com.