Home / 510(k) Clearances / K162046

510(k) K162046

MINNE TIES MMF Suture System by Summit Medical, Inc. — Product Code DYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2017
Date Received
July 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lock, Wire, And Ligature, Intraoral
Device Class
Class II
Regulation Number
872.4600
Review Panel
DE
Submission Type

Other clearances by Summit Medical, Inc.

  • K180528 — InstruSafe(R) Sterilization Container (November 16, 2018)
  • K173110 — GRAFTSITE (May 18, 2018)
  • K170388 — ANCHORMAN Tibial Ligament Fixation Device (July 25, 2017)
  • K151166 — Instru-Safe Instrument Protection System (August 18, 2015)
  • K150540 — Instru-Safe Instrument Protection System (June 22, 2015)
  • K142768 — Instru-Safe Instrument Protection System (May 29, 2015)
  • K142630 — Instru-Safe Instrument Protection System (December 23, 2014)
  • K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (December 15, 2014)
  • K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (June 27, 2014)
  • K133015 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (March 13, 2014)

Other clearances for product code DYX

  • K061271 — ERCH ARCH BAR, MODEL 38-690-00 (June 30, 2006)
  • K031207 — SAFETY RELEASE ARCH BAR KIT (July 15, 2003)
  • K030605 — RAPID IMF (June 27, 2003)
  • K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (September 14, 1999)
  • K991004 — SYNTHES QUICK LOCK IMF SYSTEM (June 23, 1999)
  • K925106 — IMPLANTABLE PULSE GENERATORS (October 6, 1993)
  • K925712 — RELIANCE SHORT STICK TIE (January 11, 1993)
  • K910090 — DIMAC WIRES (July 25, 1991)
  • K863799 — JAW FIXATION ASSEMBLY (October 14, 1986)
  • K820944 — DENTAL ARCH BAR (May 5, 1982)