FDA device listing

14MM NO-PROFILE TISSUE WASHER,18MM NO-PROFILE TISSUE WASHER,20MM NO-PROFILE TISSUE WASHER,24MM 6MM CANCELLOUS SCREW,26MM…

FDA device listing 1939863758 · Celestica de Monterrey S.A. de C.V.

Key facts

Proprietary names 14MM NO-PROFILE TISSUE WASHER,18MM NO-PROFILE TISSUE WASHER,20MM NO-PROFILE TISSUE WASHER,24MM 6MM CANCELLOUS SCREW,26MM 6MM CANCELLOUS SCREW,28MM 6MM CANCELLOUS SCREW,30MM 6MM CANCELLOUS SCREW,32MM 6MM CANCELLOUS SCREW,34MM 6MM CANCELLOUS SCREW,36MM 6MM CANCELLOUS SCREW,38MM 6MM CANCELLOUS SCREW,40MM 6MM CANCELLOUS SCREW,42MM 6MM CANCELLOUS SCREW,44MM 6MM CANCELLOUS SCREW,48MM 6MM CANCELLOUS…
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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