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Device Explorer · FDA GUDID · GMDN 44869

Orthopaedic graft inserter, reusable

A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a

US‑registered devices330in commercial distribution
Companies45labelers on GUDID
Single‑use6%of device records
Sterile3%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.5416%
Devemed Gmbh4313%
Seaspine Orthopedics Corporation237%
Karl Storz Gmbh & Co. Kg206%
Arthrex, Inc.175%
Synthes Gmbh175%
Biomet Orthopedics, Llc165%
Ctl Medical Corporation144%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.5416%
Devemed Gmbh4313%
Seaspine Orthopedics Corporation237%
Karl Storz Gmbh & Co. Kg206%
Arthrex, Inc.175%
Synthes Gmbh175%
Biomet Orthopedics, Llc165%
Ctl Medical Corporation144%
Nuvasive, Inc.134%
Wheelhouse Medical113%
Orthofix Us Llc113%
Depuy Mitek, Llc103%

Company = labeler of record on GUDID. 45 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAReicodentdevemedn.a.ROI-TArthrex®BOSS InstrumentsLollypop Graft InserterBone Dowel PlungerBone Graft Harvester PlungerCoRoentTLXXLXTriadNuVasiveCD HORIZON® Spinal 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 INSTRUMENT84
LXHOrthopedic Manual Surgical Instrument53
LXHOrthopedic manual surgical instrument43
DZNInstruments, Dental Hand31
MAXIntervertebral fusion device with bone graft, lumbar26
NBHAccessories, arthroscopic18

GMDN & GCC registration

  • GMDN code 44869 · non‑implantable
  • Single‑use 6% · sterile 3% · Rx‑only 89% · 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) · 3Width (Millimeter) · 1

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

How many orthopaedic graft inserter, reusable products are registered in the US?

330 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic graft inserter, reusable", from 45 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 16% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), LXH (Orthopedic manual surgical instrument), DZN (Instruments, Dental Hand)

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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