Device Explorer · FDA GUDID · GMDN 63819

Spinal guidewire

A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

US‑registered devices542in commercial distribution
Companies34labelers on GUDID
Single‑use59%of device records
Sterile4%labelled sterile
Prescription81%Rx‑only share
ShareLinkedIn

Share of device records

Alphatec Spine, Inc.12824%
Ctl Medical Corporation6612%
Xtant Medical Holdings, Inc.468%
Highridge Medical, Llc306%
Choice Spine, Lp265%
Premia Spine Ltd234%
Next Orthosurgical, Inc.204%
Integrity Implants Inc.173%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.12824%
Ctl Medical Corporation6612%
Xtant Medical Holdings, Inc.468%
Highridge Medical, Llc306%
Choice Spine, Lp265%
Premia Spine Ltd234%
Next Orthosurgical, Inc.204%
Integrity Implants Inc.173%
Promethean Restorative Llc173%
Vb Spine Llc173%
Stryker Corporation163%
Medtronic Sofamor Danek, Inc.163%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LITeES2 SPINAL SYSTEMXIA PRECISIONK-Wire, Blunt Sharp Tip, L=284, Ø1.7mm Short scrK -Wire, Cr Co, Blunt Sharp Tip, L=289, Ø1.65mm K-Wire, Blunt Beveled Tip, L=335,Ø 1.7 mm KWANiti#2 Wire, Blunt Blunt Tip, L=470, Ø1.5mm OverK-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.DrillK-Wire, CoCr, Blunt Sharp Tip, L=457, Ø1.7mm XL K-Wire, Blunt Sharp Tip, L=565, Ø1.6 -0.05 mm P.Niti#1 Wire, Blunt Beveled Tip, L=470, Ø1.7mm OvK-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWAK-Wire, CrCo, Blunt Sharp Tip, L=340, Ø1.65mm DKNiti#1 Wire, Blunt Blunt Tip, L=470, Ø1.7mm OverNiti#1 Wire, Blunt Sharp Tip, L=470, Ø1.7mm OverK-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA

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

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT156
LXHOrthopedic manual surgical instrument104
LXHOrthopedic Manual Surgical Instrument80
FZXGuide, Surgical, Instrument68
NKBThoracolumbosacral Pedicle Screw System29
KWPAppliance, Fixation, Spinal Interlaminal26

GMDN & GCC registration

  • GMDN code 63819 · non‑implantable
  • Single‑use 59% · sterile 4% · Rx‑only 81% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 57Outer Diameter (Millimeter) · 47Depth (Millimeter) · 10Width (Millimeter) · 5Guidewire Diameter (Millimeter) · 2Length (Inch) · 2

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

How many spinal guidewire products are registered in the US?

542 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal guidewire", from 34 companies. The largest labeler is Alphatec Spine, Inc. with 24% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument), FZX (Guide, 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.

How do I get quotes?

Add spinal guidewire to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Spinal guidewire

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying spinal guidewire for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →