ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K072322
Device Name ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact julie acker
Correspondent
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact julie acker
Regulation Number 878.5000
Classification Product Code
GAT  
Date Received 08/20/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No