SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K110545
Device Name SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact elizabeth lavelle
Correspondent
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact elizabeth lavelle
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 02/25/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No