510(k) K102339

CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE by Conmed Linvatec — Product Code GAT

K102339 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on November 23, 2010. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Conmed Linvatec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2010
Date Received
August 18, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type