EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111471
Device Name EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
Applicant
MEDSHAPE SOLUTIONS, INC
1575 northside drive nw
suite 440
atlanta, 
GA 
30318

Applicant Contact jack c griffis, iii
Correspondent
MEDSHAPE SOLUTIONS, INC
1575 northside drive nw
suite 440
atlanta, 
GA 
30318

Correspodent Contact jack c griffis, iii
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received 05/27/2011
Decision Date 06/10/2011
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