PSL ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K103819
Device Name PSL ANTERIOR 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 12/30/2010
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