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510(k) K181633

MTF Pre-Sutured Tendon by Musculoskeletal Transplant Foundation — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2019
Date Received
June 20, 2018
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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  • K110003 — MTF NEW BONE VOID FILLER (October 13, 2011)
  • K103784 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY (October 2, 2009)
  • K091218 — DBX DEMINERALIZED BONE MATRIX PUTTY (September 28, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)
  • K080405 — SYGNAL DBM (August 28, 2008)

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  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
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  • K234079 — HyperSuture Extension Line (May 10, 2024)
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  • K230311 — HyperSuture (November 24, 2023)