FDA device listing

Gauge, Depth

FDA device listing 1277725811 · Zavation Medical Products LLC

Key facts

Proprietary names Gauge, Depth
Owner/operator Zavation Medical Products LLC
Owner/operator number 10055475
Product codes HTJ
Device names HTJ - Gauge, Depth
Device class Class I
Classification regulations (21 CFR) 888.4300
Review panels Orthopedic
Registered establishments ZAVATION
Establishment registrations 3008583793
FEI numbers 3008583793
Establishment operations Complaint File Establishment
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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