FDA device listing

Zimmer (LN,LS) - Biomet Headless Compression And Twist-Off Screws

FDA device listing 2028223346 · STERIS Corporation

Key facts

Proprietary names Zimmer (LN,LS) - Biomet Headless Compression And Twist-Off Screws
Owner/operator STERIS Corporation
Owner/operator number 1527821
Product codes HWC
Device names HWC - Screw, Fixation, Bone
Device class Class II
Classification regulations (21 CFR) 888.3040
Review panels Orthopedic
Registered establishments Isomedix Operations, Inc.
Establishment registrations 1424263, 1450662
FEI numbers 1450662, 3003015552
Establishment operations Contract Sterilizer
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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