FDA device listing

Biomet Cannulated Screw System,Parrell Wire Guide

FDA device listing 2043344839 · Tecomet

Key facts

Proprietary names Biomet Cannulated Screw System,Parrell Wire Guide
Owner/operator Tecomet
Owner/operator number 1828464
Product codes HWC
Device names HWC - Screw, Fixation, Bone
Device class Class II
Classification regulations (21 CFR) 888.3040
Review panels Orthopedic
Registered establishments SYMMETRY MEDICAL, INC. - MANCHESTER, SYMMETRY MEDICAL MANUFACTURING INC, SYMMETRY MEDICAL MANUFACTURING INC.
Establishment registrations 1221053, 1828464, 3005061536
FEI numbers 1221053, 1828464, 3005061536
Establishment operations Contract 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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