MAESTRO WRIST FRACTURE IMPLANT


Device Classification Name

prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained

510(k) Number K080426
Device Name MAESTRO WRIST FRACTURE IMPLANT
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
po box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia sandborn beres
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
po box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia sandborn beres
Regulation Number 888.3800
Classification Product Code
JWJ  
Date Received 02/20/2008
Decision Date 07/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No