FIGURE 8 STERNOTOMY CLOSURE DEVICE


Device Classification Name

cerclage, fixation

510(k) Number K110541
Device Name FIGURE 8 STERNOTOMY CLOSURE DEVICE
Applicant
FIGURE 8 SURGICAL, INCORPORATED
155-a moffett park drive,
suite 210
sunnyvale, 
CA 
94089

Applicant Contact kit cariquitan
Correspondent
FIGURE 8 SURGICAL, INCORPORATED
155-a moffett park drive,
suite 210
sunnyvale, 
CA 
94089

Correspodent Contact kit cariquitan
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 02/25/2011
Decision Date 07/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No