FDA device listing

AUTOCLAVABLE TRAY,BIOANCHOR INSTRUMENT TRAY,BIO INSTABILITY INTRUMENT TRAY,BULLSEYE TRAY,COOLING BIN,CRUCIATE…

FDA device listing 1888955528 · CONMED CORPORATION

Key facts

Proprietary names AUTOCLAVABLE TRAY,BIOANCHOR INSTRUMENT TRAY,BIO INSTABILITY INTRUMENT TRAY,BULLSEYE TRAY,COOLING BIN,CRUCIATE RECONST,E9000 BUR RACK,FOREARM STRAP,GRAFIX GRAFT INSTRUMENT TRAY,HALL,HandStand,INSTABILITY TRAY,INSTRUMENT CASE,MENISCUS INSTRUMENT TRAY,MICROFREE,MICROMITE INSTRUMENT TRAY,MINI-REVO,PINN ACL DROSSPIN,Pinn-ACL TRAY,RCR INSTRUMENT TRAY,SHUTT MASTER SET,TRACTION TOWER,TUNNEL…
Owner/operator CONMED CORPORATION
Owner/operator number 1317214
Product codes FSM
Device names FSM - Tray, Surgical, Instrument
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments CONMED CORPORATION, Linvatec Corporation
Establishment registrations 1017294, 1320894
FEI numbers 1017294, 3001451571
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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