VERTIFLEX DIRECT DECOMPRESSION SYSTEM


Device Classification Name

arthroscope

510(k) Number K122662
Device Name VERTIFLEX DIRECT DECOMPRESSION 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 888.1100
Classification Product Code
HRX  
Date Received 08/31/2012
Decision Date 11/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No