FDA device listing

Pace Surgical Instruments

FDA device listing 1918347953 · Pace Surgical

Key facts

Proprietary names Pace Surgical Instruments
Owner/operator Pace Surgical
Owner/operator number 10094629
Product codes HXX
Device names HXX - Screwdriver
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments PACE SURGICAL
Establishment registrations 3042765769
FEI numbers 3042765769
Establishment operations 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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