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510(k) K031555

SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM by Synthes (Usa) — Product Code LXC

K031555 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 2003. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device. Synthes (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2003
Date Received
May 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
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 LXC

  • K251900 — MY01 Continuous Compartmental Pressure Monitor (January 16, 2026)
  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1) (April 14, 2023)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K210525 — MY01 Continuous Compartmental Pressure Monitor (April 22, 2021)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)
  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K090961 — TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS (June 12, 2009)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)

FDA data resources