2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K081511
Device Name 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact janice haselton
Correspondent
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact janice haselton
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Codes
HWC   JDR  
Date Received 05/29/2008
Decision Date 08/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No