HEALIX KNOTLESS(TM) ANCHOR


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K112249
Device Name HEALIX KNOTLESS(TM) ANCHOR
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

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

Correspodent Contact deep pal
Regulation Number 888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received 08/05/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No