SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K021379
Device Name SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
Original Applicant
ORTHO TEC LLC
8202 sherman rd.
chesterland, 
OH 
44026 -2141

Original Contact karen e warden
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received 05/01/2002
Decision Date 05/31/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No