Consulting Wallah › Device Explorer › Orthopaedic implants › Internal spinal fixation procedure kit, single-use
Device Explorer · FDA GUDID · GMDN 61300

Internal spinal fixation procedure kit, single-use

A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage impl

US‑registered devices1,283in commercial distribution
Companies15labelers on GUDID
Single‑use30%of device records
Sterile8%labelled sterile
Prescription33%Rx‑only share
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Share of device records

Sintx Technologies, Inc.86667%
Vb Spine Llc18414%
Nuvasive, Inc.15312%
Elevation Spine, Inc.464%
Providence Medical Technology, Inc.101%
Neo Medical Sa71%
Getset Surgical Sa40%
Ulrich Gmbh & Co. Kg30%

Top labelers

CompanyDevicesShare
Sintx Technologies, Inc.86667%
Vb Spine Llc18414%
Nuvasive, Inc.15312%
Elevation Spine, Inc.464%
Providence Medical Technology, Inc.101%
Neo Medical Sa71%
Getset Surgical Sa40%
Ulrich Gmbh & Co. Kg30%
Restor3D, Inc.30%
Ctl Medical Corporation20%
Precision Spine, Inc.10%
Absolute Advantage Medical, Llc10%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

neon³ CT spinal stabilizationN/AReLineLateralALIFMaXcessXLIFArchonVuePointArmadaGradientHelixSpheRxPCMPreceptXLIF Decade PlateHalo

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ODPIntervertebral Fusion Device With Bone Graft, Cervical882
MAXIntervertebral Fusion Device With Bone Graft, Lumbar866
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT170
LXHOrthopedic manual surgical instrument132
KWQAppliance, Fixation, Spinal Intervertebral Body48
OVEIntervertebral Fusion Device With Integrated Fixation, Cervi44

GMDN & GCC registration

  • GMDN code 61300 · non‑implantable
  • Single‑use 30% · sterile 8% · Rx‑only 33% · OTC 67%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Millimeter) · 576Length (Millimeter) · 567Width (Millimeter) · 519Outer Diameter (Millimeter) · 24

Use these as the dimensions to specify in a tender line.

How many internal spinal fixation procedure kit, single-use products are registered in the US?

1,283 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal spinal fixation procedure kit, single-use", from 15 companies. The largest labeler is Sintx Technologies, Inc. with 67% of records.

Which FDA product codes apply?

ODP (Intervertebral Fusion Device With Bone Graft, Cervical), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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