BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K991715
Device Name BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
Applicant
LINVATEC CORP.
11311 concept blvd.
largo, 
FL 
33773 -4908

Applicant Contact laura seneff
Correspondent
LINVATEC CORP.
11311 concept blvd.
largo, 
FL 
33773 -4908

Correspodent Contact laura seneff
Regulation Number 888.3030
Classification Product Code
MAI  
Subsequent Product Code
HTY  
Date Received 05/20/1999
Decision Date 08/06/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No