AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K022207
Device Name AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
Original Applicant
AXYA MEDICAL, INC.
100 cummings center
suite 444c
beverly, 
MA 
01915

Original Contact howard l schrayer
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Codes
GAS   HWC  
Date Received 07/08/2002
Decision Date 10/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No