GENESYS PRESSFT SUTURE ANCHOR


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K121890
Device Name GENESYS PRESSFT SUTURE ANCHOR
Applicant
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 concept boulevard
largo, 
FL 
33773

Applicant Contact lorna k linville
Correspondent
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 concept boulevard
largo, 
FL 
33773

Correspodent Contact lorna k linville
Regulation Number 888.3030
Classification Product Code
MAI  
Date Received 06/28/2012
Decision Date 08/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No