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Device Explorer · FDA GUDID · GMDN 47807

Surgical implant/trial-implant/sizer holder, reusable

A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing,

US‑registered devices5,169in commercial distribution
Companies140labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Meditech Spine, Llc4689%
Medtronic Sofamor Danek, Inc.3537%
Zavation Llc3336%
Alphatec Spine, Inc.3206%
Omnia Medical, Llc2585%
Curiteva, Inc.2114%
Synthes Gmbh2094%
Globus Medical, Inc.1964%

Top labelers

CompanyDevicesShare
Meditech Spine, Llc4689%
Medtronic Sofamor Danek, Inc.3537%
Zavation Llc3336%
Alphatec Spine, Inc.3206%
Omnia Medical, Llc2585%
Curiteva, Inc.2114%
Synthes Gmbh2094%
Globus Medical, Inc.1964%
Arthrex, Inc.1934%
Spineart Sa1894%
Smith & Nephew, Inc.1884%
Nuvasive, Inc.1874%

Company = labeler of record on GUDID. 140 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAINSTRUMENTAVIATORReflex HybridLITe PLATE SYSTEMDYNATRANREFLEX HYBRIDXIA 3CENTAURO.I.C. TITANIUMREUNIONAXSOSAVS Anchor-LANCHORAGEGIRO GROWTH MODULATION SYSTEMHINGE PEDIATRIC PLATING SYSTEM

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 INSTRUMENT879
MAXIntervertebral fusion device with bone graft, lumbar563
LXHOrthopedic Manual Surgical Instrument473
MAXIntervertebral Fusion Device With Bone Graft, Lumbar466
ODPIntervertebral Fusion Device With Bone Graft, Cervical368
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba355

GMDN & GCC registration

  • GMDN code 47807 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 88% · 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

Height (Millimeter) · 617Width (Millimeter) · 501Angle (degree) · 355Length (Millimeter) · 342Depth (Millimeter) · 100Outer Diameter (Millimeter) · 96

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

How many surgical implant/trial-implant/sizer holder, reusable products are registered in the US?

5,169 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical implant/trial-implant/sizer holder, reusable", from 140 companies. The largest labeler is Meditech Spine, Llc with 9% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), MAX (Intervertebral fusion device with bone graft, lumbar), LXH (Orthopedic Manual Surgical Instrument), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)

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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