Establishment registration

SPINAL ELEMENTS, INC.

FDA establishment registration 3004893332 · CARLSBAD, US

Key facts

Registration number 3004893332
Establishment name SPINAL ELEMENTS, INC.
Owner/operator Spinal Elements
Owner/operator number 9048980
FEI number 3004893332
Address 3115 Melrose Dr Suite 200
City CARLSBAD
State CA
Country US
Establishment types Specification developer
Registration valid through 2026
Product codes listed BSO, ETN, FSM, FST, HAE, HAW, HRX, HTT, HTW, HTY, JDQ, JDW, KWP, KWQ, LXH, MAX, MNH, MNI, MQP, MRW, NKB, NKG, ODP, OLO, OSH, OVD, OVE, OWI, PEK
Device classes 1, 2, U

At a glance

  • 100–999 Device listings
  • 1,000+ UDI devices (GUDID)
  • Current Registration current
  • 1–9 FDA inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device establishment registrations