Consulting Wallah › Device Explorer › Orthopaedic implants › Spinal fixation plate, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 46653

Spinal fixation plate, non-bioabsorbable

A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absor

US‑registered devices28,563in commercial distribution
Companies101labelers on GUDID
Single‑use90%of device records
Sterile18%labelled sterile
Prescription83%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Diomedical Co.,Ltd.4,00514%
Zavation Llc2,78310%
Nuvasive, Inc.1,6236%
Globus Medical, Inc.1,3695%
L&K Biomed Co. ,Ltd.1,1374%
Alphatec Spine, Inc.1,1154%
Seaspine Orthopedics Corporation9303%
Vb Spine Llc8533%

Top labelers

CompanyDevicesShare
Diomedical Co.,Ltd.4,00514%
Zavation Llc2,78310%
Nuvasive, Inc.1,6236%
Globus Medical, Inc.1,3695%
L&K Biomed Co. ,Ltd.1,1374%
Alphatec Spine, Inc.1,1154%
Seaspine Orthopedics Corporation9303%
Vb Spine Llc8533%
Astura Medical7953%
Life Spine, Inc.7263%
Gbs Commonwealth Co.,Ltd.6752%
Medtronic Sofamor Danek, Inc.6472%

Company = labeler of record on GUDID. 101 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LITe Plate SystemESCALATEAVIATORREFLEX HYBRIDCarboClear Cervical Plate SystemBiolign RotolocAxisOASYSVERTICALENEON 3mambo™ modular cervical plate systemneon³™ OCT spinal stabilizationCOSYMONOPOLY/CONKLUSIONASCOTCERVICAL 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
KWQAppliance, Fixation, Spinal Intervertebral Body8,912
KWQAppliance, fixation, spinal intervertebral body6,589
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY6,222
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba2,526
MAXIntervertebral fusion device with bone graft, lumbar1,727
ODPIntervertebral fusion device with bone graft, cervical1,640

GMDN & GCC registration

  • GMDN code 46653 · implantable
  • Single‑use 90% · sterile 18% · Rx‑only 83% · 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) · 8,130Outer Diameter (Millimeter) · 1,590Width (Millimeter) · 1,313Height (Millimeter) · 1,261Angle (degree) · 705Depth (Millimeter) · 340

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

How many spinal fixation plate, non-bioabsorbable products are registered in the US?

28,563 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal fixation plate, non-bioabsorbable", from 101 companies. The largest labeler is Diomedical Co.,Ltd. with 14% of records.

Which FDA product codes apply?

KWQ (Appliance, Fixation, Spinal Intervertebral Body), KWQ (Appliance, fixation, spinal intervertebral body), KWQ (APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba)

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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