FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K103838
Device Name FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Applicant
PRECISION SURGERY LTD.
8202 sherman road
chesterland, 
OH 
44026 -2141

Applicant Contact karen e warden, phd.
Correspondent
PRECISION SURGERY LTD.
8202 sherman road
chesterland, 
OH 
44026 -2141

Correspodent Contact karen e warden, phd.
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 12/30/2010
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No