ACCIN TOTAL KNEE SYSTEM


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K081127
Device Name ACCIN TOTAL KNEE SYSTEM
Applicant
ACCELERATED INNOVATION, LLC
1033 us highway 46 east
suite a204
clifton, 
NJ 
07013

Applicant Contact michael kvitnitsky
Correspondent
ACCELERATED INNOVATION, LLC
1033 us highway 46 east
suite a204
clifton, 
NJ 
07013

Correspodent Contact michael kvitnitsky
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 04/21/2008
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No