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510(k) K052799

MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM by Bonutti Research, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2005
Date Received
October 3, 2005
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

Other clearances by Bonutti Research, Inc.

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  • K090175 — UNITY BETA PLLA SYSTEM (September 10, 2009)
  • K082906 — UNITY BETA ANCHOR SYSTEM (October 30, 2008)
  • K062820 — UNITY ALPHA SYSTEM (March 15, 2007)
  • K060283 — TRANSET SYSTEM (February 22, 2006)
  • 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)
  • K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (May 8, 2001)

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