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Device Explorer · FDA GUDID · GMDN 60847

Polymeric spinal fusion cage, sterile

A 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 and

US‑registered devices9,246in commercial distribution
Companies26labelers on GUDID
Single‑use93%of device records
Sterile91%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Aurora Spine, Inc.2,36626%
Meditech Spine, Llc2,21324%
Cutting Edge Spine, Llc1,17813%
Ldr Spine Usa, Inc.7218%
Biomet Spine Llc6487%
Corentec Co., Ltd5025%
Choice Spine, Lp2673%
Centinel Spine, Llc2633%

Top labelers

CompanyDevicesShare
Aurora Spine, Inc.2,36626%
Meditech Spine, Llc2,21324%
Cutting Edge Spine, Llc1,17813%
Ldr Spine Usa, Inc.7218%
Biomet Spine Llc6487%
Corentec Co., Ltd5025%
Choice Spine, Lp2673%
Centinel Spine, Llc2633%
Linkspine, Inc.1822%
Spinevision1802%
Spineology Inc.1402%
Spine Innovation, Llc1041%

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

Brand names on the register (sample)

Idys®-ALIF TiVacIdys™- ALIFIdys™- LIFTWIN PEAKSSpaceVision® OLIFSpaceVision® PLIFSpaceVision® TLIFAvenue TMC+InterBRIDGEROI-CROIROI-TROI-AAvenue LEasyspine

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, Lumbar3,795
MAXIntervertebral fusion device with bone graft, lumbar3,390
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba776
ODPIntervertebral fusion device with bone graft, cervical568
ODPIntervertebral Fusion Device With Bone Graft, Cervical423
MQPSpinal Vertebral Body Replacement Device331

GMDN & GCC registration

  • GMDN code 60847 · non‑implantable
  • Single‑use 93% · sterile 91% · Rx‑only 100% · 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 (Millimeter) · 4,369Height (Millimeter) · 4,065Width (Millimeter) · 3,510Angle (degree) · 3,276Depth (Millimeter) · 761Outer Diameter (Millimeter) · 4

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

How many polymeric spinal fusion cage, sterile products are registered in the US?

9,246 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric spinal fusion cage, sterile", from 26 companies. The largest labeler is Aurora Spine, Inc. with 26% of records.

Which FDA product codes apply?

MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), MAX (Intervertebral fusion device with bone graft, lumbar), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba), 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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