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510(k) K130422

PHANTOM FIBER BIOFIBER SUTURE by Tornier, Inc. — Product Code NWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2013
Date Received
February 20, 2013
Clearance Type
Special
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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  • K211359 — Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient (November 12, 2021)
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Other clearances for product code NWJ

  • K211307 — GalaSTITCH Absorbable Monofilament Suture (May 27, 2021)
  • K132348 — TEPHAFLEX BRAIDED SUTURE (September 5, 2013)
  • K122487 — BIOFIBER SYTURE (September 17, 2012)
  • K100876 — AESCULAP MONOMAX ABSORBABLE SUTURE (July 14, 2010)
  • K082178 — TEPHAFLEX ABSORBABLE SUTURE (October 30, 2008)
  • K081099 — TEPHAFLEX ABSORBABLE SUTURE (July 15, 2008)
  • K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 (November 16, 2007)
  • DEN060003 — TEPHAFLEX ABSORBABLE SUTURE (February 8, 2007)