Consulting Wallah › Device Explorer › Other devices › Orthopaedic surgical distractor, internal
Device Explorer · FDA GUDID · GMDN 56637

Orthopaedic surgical distractor, internal

A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It t

US‑registered devices3,298in commercial distribution
Companies96labelers on GUDID
Single‑use8%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.78024%
Highridge Medical, Llc2608%
Seaspine Orthopedics Corporation2558%
Depuy Spine, Llc2237%
Altus Spine, Llc2167%
Eit Emerging Implant Technologies Gmbh1133%
Globus Medical, Inc.923%
Integrity Implants Inc.863%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.78024%
Highridge Medical, Llc2608%
Seaspine Orthopedics Corporation2558%
Depuy Spine, Llc2237%
Altus Spine, Llc2167%
Eit Emerging Implant Technologies Gmbh1133%
Globus Medical, Inc.923%
Integrity Implants Inc.863%
Astura Medical762%
Zsfab, Inc.642%
Spineart Sa612%
Ctl Medical Corporation582%

Company = labeler of record on GUDID. 96 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OASYSRELIANCERELIANCE ALAVS Anchor-C Cervical Cage SystemES2 SPINAL SYSTEMXIA 3XIA 4.5XIA 4.5 System - XIA CTDistractorDistractor for Open ProcedureCompressorCompressor for Open ProcedureCurved DistractorMIS CompressorAxis Spine Technologies ALIF System InstrumentOrthoSolutions 'System26' Bone Screws

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 instrument1,055
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT793
LXHOrthopedic Manual Surgical Instrument756
GADRETRACTOR194
MAXIntervertebral Fusion Device With Bone Graft, Lumbar124
HWBEXTRACTOR108

GMDN & GCC registration

  • GMDN code 56637 · non‑implantable
  • Single‑use 8% · sterile 0% · 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

Width (Millimeter) · 91Length (Millimeter) · 86Height (Millimeter) · 75Length (Inch) · 22Lumen/Inner Diameter (Millimeter) · 4

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

How many orthopaedic surgical distractor, internal products are registered in the US?

3,298 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic surgical distractor, internal", from 96 companies. The largest labeler is Medtronic Sofamor Danek, 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), GAD (RETRACTOR)

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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