ROG KNOTLESS SUTURE ANCHOR


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K110230
Device Name ROG KNOTLESS SUTURE ANCHOR
Applicant
ROG SPORTS MEDICINE, INC.
80 shelton technology center
shelton, 
CT 
06484

Applicant Contact curtis raymond
Correspondent
ROG SPORTS MEDICINE, INC.
80 shelton technology center
shelton, 
CT 
06484

Correspodent Contact curtis raymond
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 01/26/2011
Decision Date 05/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No