IST ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K072650
Device Name IST ANTERIOR CERVICAL PLATE SYSTEM
Applicant
INNOVATIVE SPINAL TECHNOLOGIES INC
111 forbes blvd.
mansfield, 
MA 
02048

Applicant Contact gina yeh
Correspondent
INNOVATIVE SPINAL TECHNOLOGIES INC
111 forbes blvd.
mansfield, 
MA 
02048

Correspodent Contact gina yeh
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 09/19/2007
Decision Date 11/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No