510(k) K140643

GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY by Depuy Mitek, A Johnson And Johnson Company — Product Code MAI

K140643 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson And Johnson Company for the device "GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on Jul 8, 2014. 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 And Johnson Company has 61 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 8, 2014
Date Received
Mar 12, 2014
Clearance Type
Traditional
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 K140643. Report a data issue: hello@regdatalab.com.