COMPOSITE HITCH SUTURE ANCHOR


Device Classification Name

staple, fixation, bone

510(k) Number K081172
Device Name COMPOSITE HITCH SUTURE ANCHOR
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

Applicant Contact becky earl
Correspondent
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact becky earl
Regulation Number 888.3030
Classification Product Code
JDR  
Subsequent Product Code
HWC  
Date Received 04/24/2008
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No