Consulting Wallah › Device Explorer › Orthopaedic implants › Spinal intraoperative positioning/manipulation pin
Device Explorer · FDA GUDID · GMDN 66937

Spinal intraoperative positioning/manipulation pin, single-use

A nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgic

US‑registered devices111in commercial distribution
Companies13labelers on GUDID
Single‑use59%of device records
Sterile35%labelled sterile
Prescription46%Rx‑only share
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Share of device records

Tedan Surgical Innovations, L.L.C.4843%
Alphatec Spine, Inc.1514%
Thompson Surgical Instruments, Inc.1211%
Medtronic Sofamor Danek, Inc.76%
Spineology Inc.65%
Centinel Spine, Llc55%
Ortho Development Corporation55%
Life Spine, Inc.55%

Top labelers

CompanyDevicesShare
Tedan Surgical Innovations, L.L.C.4843%
Alphatec Spine, Inc.1514%
Thompson Surgical Instruments, Inc.1211%
Medtronic Sofamor Danek, Inc.76%
Spineology Inc.65%
Centinel Spine, Llc55%
Ortho Development Corporation55%
Life Spine, Inc.55%
Medfix International, Llc22%
Surgical Direct, Inc.22%
Stryker Leibinger Gmbh & Co. Kg22%
Medynus, Inc.11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TSIProdisc C, SK, Vivo, Nova InstrumentLDR Spine USA3CorThompsonImpeace Cervical Plate SystemGeneral Instrumentsn/aMedfixMedtronic Reusable InstrumentsN/AGruve Anterior Cervical Plate SystemSimpact Tri-FinSolstice Occipito-Cervico-Thoracic SystemSegmental Plating SystemSigma

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 Instrument39
MDMInstrument, Manual, Surgical, General Use30
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT20
LXHOrthopedic manual surgical instrument17
QLQManual Instruments Designed For Use With Total Disc Replacem5
FZXGuide, surgical, instrument3

GMDN & GCC registration

  • GMDN code 66937 · non‑implantable
  • Single‑use 59% · sterile 35% · Rx‑only 46% · 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) · 28Outer Diameter (Millimeter) · 3Needle Gauge (Gauge) · 3Length (Centimeter) · 3

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

How many spinal intraoperative positioning/manipulation pin, single-use products are registered in the US?

111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal intraoperative positioning/manipulation pin, single-use", from 13 companies. The largest labeler is Tedan Surgical Innovations, L.L.C. with 43% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), MDM (Instrument, Manual, Surgical, General Use), 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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