ACCIN UNIPOLAR HEAD SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K080539
Device Name ACCIN UNIPOLAR HEAD 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 888.3350
Classification Product Code
JDI  
Date Received 02/27/2008
Decision Date 06/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No