GRYPHON BR AND HEALIX BR ANCHORS


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K073412
Device Name GRYPHON BR AND HEALIX BR ANCHORS
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact ruth forstadt
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact ruth forstadt
Regulation Number 888.3030
Classification Product Code
MAI  
Date Received 12/04/2007
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls