BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110574
Device Name BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
Applicant
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact sheryl malmberg
Correspondent
BIOMET MICROFIXATION, INC.
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact sheryl malmberg
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 03/01/2011
Decision Date 05/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls