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Device Explorer · FDA GUDID · GMDN 44874

Orthopaedic graft guide

A device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior crucia

US‑registered devices154in commercial distribution
Companies11labelers on GUDID
Single‑use11%of device records
Sterile10%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Alphatec Spine, Inc.8555%
Arthrex, Inc.4630%
Altus Spine, Llc85%
Smith & Nephew, Inc.43%
Highridge Medical, Llc21%
Integrity Implants Inc.21%
Ace Surgical Supply Co., Inc.21%
Conmed Corporation21%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.8555%
Arthrex, Inc.4630%
Altus Spine, Llc85%
Smith & Nephew, Inc.43%
Highridge Medical, Llc21%
Integrity Implants Inc.21%
Ace Surgical Supply Co., Inc.21%
Conmed Corporation21%
Biomet Orthopedics, Llc11%
Providence Medical Technology, Inc.11%
Si-Bone Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TC-PLUSFlareHawkNAArthrex®CDO SystemCORUS™ Allograft Delivery InstrumentImola-SilverstoneGeneral InstrumentsGeneral InstrumentN/AIdentiTi8-Gauge Bone Access Needle and TampACEAMP-LTXCalibrateBattalion

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 INSTRUMENT79
LXHOrthopedic manual surgical instrument46
HWTTEMPLATE9
MAXIntervertebral fusion device with bone graft, lumbar8
NBHACCESSORIES,ARTHROSCOPIC6
LXHOrthopedic Manual Surgical Instrument4

GMDN & GCC registration

  • GMDN code 44874 · non‑implantable
  • Single‑use 11% · sterile 10% · Rx‑only 95% · 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 (Centimeter) · 1Length (Inch) · 1Width (Inch) · 1

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

How many orthopaedic graft guide products are registered in the US?

154 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic graft guide", from 11 companies. The largest labeler is Alphatec Spine, Inc. with 55% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), HWT (TEMPLATE), 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.

How do I get quotes?

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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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