510(k) K090124

GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 by Depuy Mitek, A Johnson & Johnson Company — Product Code MAI

K090124 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814". The FDA issued a decision of Substantially Equivalent on Mar 11, 2009. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), 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
Mar 11, 2009
Date Received
Jan 21, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K090124. Report a data issue: hello@regdatalab.com.