NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K122437
Device Name NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
Applicant
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact elizabeth wray
Correspondent
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact elizabeth wray
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received 08/10/2012
Decision Date 10/18/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized