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510(k) K993115

MULTITAK SS by Bonutti Research, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1999
Date Received
September 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K060283 — TRANSET SYSTEM (February 22, 2006)
  • K052799 — MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (December 16, 2005)
  • K033717 — TRANSET FRACTURE FIXATION SYSTEM (February 25, 2004)
  • K013177 — MULTITAK SUTURE SNAP SYSTEM (December 19, 2001)
  • K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (October 29, 2001)

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