FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K073708
Device Name FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Applicant
PRECISION SURGERY LTD.
8202 sherman road
chesterland, 
OH 
44026 -2141

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

Correspodent Contact karen e warden
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 12/31/2007
Decision Date 06/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls