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510(k) K012465

MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR by Bonutti Research, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2001
Date Received
August 1, 2001
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)
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  • K013177 — MULTITAK SUTURE SNAP SYSTEM (December 19, 2001)
  • K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (May 8, 2001)

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