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510(k) K991004

SYNTHES QUICK LOCK IMF SYSTEM by Synthes (Usa) — Product Code DYX

K991004 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES QUICK LOCK IMF SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 1999. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1999
Date Received
March 25, 1999
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 Synthes (Usa)

  • K180821 — TruMatch Graft Cage - Long Bone (December 21, 2018)
  • K152239 — Zero-P Natural Plate System (December 2, 2015)
  • K131984 — SYNTHES SYNSONIC ULNA NAIL (March 31, 2014)
  • K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (May 20, 2013)
  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
  • K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (August 8, 2011)
  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code DYX

  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • 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)
  • 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)

FDA data resources