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510(k) K042899

SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS by Synthes (Usa) — Product Code HTO

K042899 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2005
Date Received
October 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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 HTO

  • K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (August 10, 2011)
  • K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (December 21, 2001)
  • K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (June 12, 2000)
  • K954915 — FLEXIBLE INTRAMEDULLARY REAMER (December 28, 1995)
  • K903248 — COMBINATION REAMER (July 30, 1990)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K870845 — WARSAW ORTHOPEDIC POINTED REAMER (March 11, 1987)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)

FDA data resources