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510(k) K032078

MITEK MICRO QUICKANCHOR by Mitek Worldwide — Product Code NOV

K032078 is an FDA 510(k) premarket notification submitted by Mitek Worldwide for the device "MITEK MICRO QUICKANCHOR". The FDA issued a decision of Substantially Equivalent on August 25, 2003. The device falls under product code NOV (Anchor, Suture, Bone Fixation, Metallic), a Class II device regulated under 21 CFR 888.3030. Mitek Worldwide has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2003
Date Received
July 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anchor, Suture, Bone Fixation, Metallic
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.

Other clearances by Mitek Worldwide

  • K032717 — BIOCRYL RAPIDE INTERFERENCE SCREW (March 31, 2004)
  • K032167 — BIO-INTRAFIX TIBIAL SCREW AND SHEATH (October 15, 2003)
  • K030995 — MINILOK QUICKANCHOR PLUS (June 26, 2003)
  • K031519 — CUFFLOK ANCHOR (June 6, 2003)
  • K031406 — EXOJET TISSUE MANAGEMENT SYSTEM (May 30, 2003)
  • K024115 — MICROFIX QUICKANCHOR PLUS (March 13, 2003)
  • K023388 — MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM (December 27, 2002)
  • K021953 — MITEK PDS/PGA STAPLE (December 20, 2002)
  • K021883 — BIOFASTIN RC THREADED SUTURE ANCHOR (July 1, 2002)

FDA data resources