BODYFORM THORACIC FIXATION SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K072407
Device Name BODYFORM THORACIC FIXATION SYSTEM
Applicant
THEKEN SPINE LLC
283 e waterloo rd.
akron, 
OH 
44319

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
283 e waterloo rd.
akron, 
OH 
44319

Correspodent Contact dale davison
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 08/27/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No