Consulting Wallah › Device Explorer › Orthopaedic implants › Metallic spinal fusion cage, non-sterile
Device Explorer · FDA GUDID · GMDN 57805

Metallic spinal fusion cage, non-sterile

A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow

US‑registered devices3,693in commercial distribution
Companies26labelers on GUDID
Single‑use97%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Diomedical Co.,Ltd.1,42639%
Altus Spine, Llc56715%
Genesys Orthopedics Systems Llc37910%
Camber Spine Technologies, Llc3289%
Astura Medical1514%
Medyssey Co., Ltd.1344%
Choice Spine, Lp1083%
Eisertech, Llc852%

Top labelers

CompanyDevicesShare
Diomedical Co.,Ltd.1,42639%
Altus Spine, Llc56715%
Genesys Orthopedics Systems Llc37910%
Camber Spine Technologies, Llc3289%
Astura Medical1514%
Medyssey Co., Ltd.1344%
Choice Spine, Lp1083%
Eisertech, Llc852%
Legend Spine Llc812%
Eminent Spine Llc652%
Alpha Ai Co.,Ltd.632%
Sintea Plustek Srl562%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

L-VarlockTraXis®InFix®ESL SPINE SPACER SYSTEMIBEX SPINAL SYSTEMX-PacNovel Spinal Spacer SystemAltus Spine Interbody Fusion SystemSuzuka Interbody Fusion SystemReliance Buttress Washer SystemZavationHALF DOMEALTATiger Shark Spinal SystemTIGER SHARK Spinal SystemTiGER SHARK Interbody Fusion System

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MAXIntervertebral fusion device with bone graft, lumbar2,087
ODPIntervertebral fusion device with bone graft, cervical1,429
MAXIntervertebral Fusion Device With Bone Graft, Lumbar1,088
ODPIntervertebral Fusion Device With Bone Graft, Cervical486
MQPSpinal Vertebral Body Replacement Device141
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE47

GMDN & GCC registration

  • GMDN code 57805 · non‑implantable
  • Single‑use 97% · sterile 0% · Rx‑only 93% · 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) · 2,921Length (Millimeter) · 1,154Width (Millimeter) · 1,027Angle (degree) · 785Depth (Millimeter) · 260Outer Diameter (Millimeter) · 6

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

How many metallic spinal fusion cage, non-sterile products are registered in the US?

3,693 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metallic spinal fusion cage, non-sterile", from 26 companies. The largest labeler is Diomedical Co.,Ltd. with 39% of records.

Which FDA product codes apply?

MAX (Intervertebral fusion device with bone graft, lumbar), ODP (Intervertebral fusion device with bone graft, cervical), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), ODP (Intervertebral Fusion Device With Bone Graft, Cervical)

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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