MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)


the company

Device Classification Name

suture, nonabsorbable, synthetic, polypropylene

510(k) Number K002435
Device Name MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
Original Applicant
AXYA MEDICAL, INC.
100 cummings center
suite 444c
beverly, 
MA 
01915

Original Contact howard l schrayer
Regulation Number 878.5010
Classification Product Code
GAW  
Subsequent Product Code
MBI  
Date Received 08/09/2000
Decision Date 08/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Special
Reviewed by Third Party No

Combination Product

No