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510(k) K131143

TRELLIS COLLAGEN RIBBON by Wrightmedicaltechnologyinc — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2013
Date Received
April 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists in tendon repair.

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