FDA device listing

De Mayo Adapt2Fit Knee Positioner,De Mayo Distractor,De Mayo Exact Fit Hip Positioner,De Mayo Exact-Fit Hip…

FDA device listing 1197057435 · INNOVATIVE MEDICAL P

Key facts

Proprietary names De Mayo Adapt2Fit Knee Positioner,De Mayo Distractor,De Mayo Exact Fit Hip Positioner,De Mayo Exact-Fit Hip Positioner,De Mayo Hip Positioner,De Mayo Knee Positioner,Expand-a-Peg,IMP Universal Lateral Hip Positioner,MorphBoard,MULTIPLE TABLE ACCESSORIES,Resnik Shoulder Holder,Swing-Arm (108MB-803SMB)
Owner/operator INNOVATIVE MEDICAL P
Owner/operator number 9006467
Product codes FWZ
Device names FWZ - Operating Room Accessories Table Tray
Device class Class I
Classification regulations (21 CFR) 878.4950
Review panels General & Plastic Surgery
Registered establishments INNOVATIVE MEDICAL PRODUCTS, INC.
Establishment registrations 1223419
FEI numbers 1000137654
Establishment operations Manufacturer, Specification Developer
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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