ACCIN BIPOLAR HEAD SYSTEM


Device Classification Name

prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

510(k) Number K080647
Device Name ACCIN BIPOLAR HEAD SYSTEM
Applicant
ACCELERATED INNOVATION, LLC
1033 us highway 46 east
suite a204
clifton, 
NJ 
07013

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

Correspodent Contact michael kvitmitsky
Regulation Number 888.3390
Classification Product Code
KWY  
Date Received 03/07/2008
Decision Date 07/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No