FDA device listing

HA minuteman G3 MIS Fusion Plate

FDA device listing 1808557605 · Life Science Outsourcing, Inc.

Key facts

Proprietary names HA minuteman G3 MIS Fusion Plate
Owner/operator Life Science Outsourcing, Inc.
Owner/operator number 10024857
Product codes PEK
Device names PEK - Spinous Process Plate
Device class Class II
Classification regulations (21 CFR) 888.3050
Review panels Orthopedic
Registered establishments LIFE SCIENCE OUTSOURCING, INC.
Establishment registrations 2031093
FEI numbers 3001236549
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

Browse all FDA device listings