FDA device listing

FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE

FDA device listing 1621806219 · DePuy Spine, Inc.

Key facts

Proprietary names FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
Owner/operator DePuy Spine, Inc.
Owner/operator number 1526439
Premarket submissions K143533
Product codes MQV
Device names MQV - Filler, Bone Void, Calcium Compound
Device class Class II
Classification regulations (21 CFR) 888.3045
Review panels Orthopedic
Registered establishments DEPUY SPINE, INC.
Establishment registrations 1526439
FEI numbers 1526439
Establishment operations Complaint File Establishment, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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