G7 ACETABULAR SYSTEM


Device Classification Name

prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive

510(k) Number K121874
Device Name G7 ACETABULAR SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact becky earl
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact becky earl
Regulation Number 888.3310
Classification Product Code
PBI  
Subsequent Product Codes
JDI   KWZ   LPH   LZO   OQG  
OQH   OQI  
Date Received 06/27/2012
Decision Date 11/23/2012
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