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510(k) K993314

SYNTHES LIGHT GUIDE by Synthes (Usa) — Product Code FQP

K993314 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES LIGHT GUIDE". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code FQP (Lamp, Operating-Room), a Class II device regulated under 21 CFR 878.4580. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
October 4, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Operating-Room
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
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 FQP

  • K001223 — ACULUX, MODEL AX3001, AX3002 (June 23, 2000)
  • K781581 — SURGICAL LIGHT 22 SERIES (October 17, 1978)
  • K770812 — HANDLES, LIGHT, SURGICAL, STEOILE (May 23, 1977)
  • K761018 — SURGICAL LIGHT - CHALLENGE 22 SERIES (January 26, 1977)

FDA data resources