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510(k) K120479

MTF FASCIA by Musculoskeletal Transplant Foundation — Product Code OWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2012
Date Received
February 16, 2012
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.

Other clearances by Musculoskeletal Transplant Foundation

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  • K110003 — MTF NEW BONE VOID FILLER (October 13, 2011)
  • K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K103784 — 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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