TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K112526
Device Name TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact melissa egan
Correspondent
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact melissa egan
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Code
MAI  
Date Received 08/31/2011
Decision Date 01/31/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No