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510(k) K122487

BIOFIBER SYTURE by Tornier, Inc. — Product Code NWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2012
Date Received
August 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Recombinant Technology
Device Class
Class II
Regulation Number
878.4494
Review Panel
SU
Submission Type

Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.

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Other clearances for product code NWJ

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  • K081099 — TEPHAFLEX ABSORBABLE SUTURE (July 15, 2008)
  • K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 (November 16, 2007)
  • DEN060003 — TEPHAFLEX ABSORBABLE SUTURE (February 8, 2007)