K’FIX


Device Classification Name

pin, fixation, smooth, metallic

510(k) Number K010847
Device Name K’FIX
Original Applicant
AVANTA ORTHOPAEDICS, INC.
9369 carroll park drive, ste.a
san diego, 
CA 
92121

Original Contact louise m focht
Regulation Number 888.3040
Classification Product Code
NDL  
Date Received 03/21/2001
Decision Date 06/19/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No