FDA device listing

30MM NOPROFILE CANCEL SCREW,30MM NOPROF SELFTAP BICORT SCR,32MM NOPROF SELFTAP BICORT SCR,34MM NOPROF SELFTAP BICORT…

FDA device listing 1484307800 · Celestica de Monterrey S.A. de C.V.

Key facts

Proprietary names 30MM NOPROFILE CANCEL SCREW,30MM NOPROF SELFTAP BICORT SCR,32MM NOPROF SELFTAP BICORT SCR,34MM NOPROF SELFTAP BICORT SCR,35MM NOPROFILE CANCEL SCREW,36MM NOPROF SELFTAP BICORT SCR,38MM NOPROF SELFTAP BICORT SCR,40MM NOPROFILE CANCEL SCREW,40MM NOPROF SELFTAP BICORT SCR,42MM NOPROF SELFTAP BICORT SCR,44MM NOPROF SELFTAP BICORT SCR,45MM NOPROFILE CANCEL SCREW,46MM NOPROF SELFTAP BICORT SCR,48MM…
Owner/operator Celestica de Monterrey S.A. de C.V.
Owner/operator number 10054863
Product codes HWC, MBI
Device names HWC - Screw, Fixation, Bone, MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Device class Class II
Classification regulations (21 CFR) 888.3040
Review panels Orthopedic
Registered establishments CELESTICA de MONTERREY S.A. de C.V.
Establishment registrations 3003139373
FEI numbers 3003139373
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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