ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K111183
Device Name ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
Applicant
ORTHOFIX INC.
3451 plano parkway
lewisville, 
TX 
75056

Applicant Contact darla chew
Correspondent
ORTHOFIX INC.
3451 plano parkway
lewisville, 
TX 
75056

Correspodent Contact darla chew
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 04/27/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No