MODIFIED VERTIFLEX SPINAL SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K073143
Device Name MODIFIED VERTIFLEX SPINAL SCREW SYSTEM
Applicant
VERTIFLEX, INC.
1351 calle avanzado
san clemente, 
CA 
92673

Applicant Contact steve reitzler
Correspondent
VERTIFLEX, INC.
1351 calle avanzado
san clemente, 
CA 
92673

Correspodent Contact steve reitzler
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
MNH   NKB  
Date Received 11/07/2007
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No