BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K111908
Device Name BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Applicant
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact kim reed
Correspondent
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact kim reed
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received 07/05/2011
Decision Date 11/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No