ACCELL EVO3 (FORMERLY ACCELL A2I)


Device Classification Name

filler, bone void, osteoinduction (w/o human growth factor)

510(k) Number K103742
Device Name ACCELL EVO3 (FORMERLY ACCELL A2I)
Applicant
INTEGRA LIFESCIENCES
2 goodyear
irvine, 
CA 
92672

Applicant Contact jenny fam
Correspondent
INTEGRA LIFESCIENCES
2 goodyear
irvine, 
CA 
92672

Correspodent Contact jenny fam
Regulation Number 888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received 12/23/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No