ARCOMXL ACTIVE ARTICULATION


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K110555
Device Name ARCOMXL ACTIVE ARTICULATION
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

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

Correspodent Contact bekcy earl
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received 02/28/2011
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No