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510(k) K102339

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

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

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  • K080444 — CONMED LINVATEC OSPREY DRILL SYSTEM (April 2, 2008)
  • K073481 — THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES (January 7, 2008)

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