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Device Explorer · FDA GUDID · GMDN 61325

Bone-screw internal spinal fixation system, non-sterile

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc diseas

US‑registered devices85,917in commercial distribution
Companies65labelers on GUDID
Single‑use96%of device records
Sterile1%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Gbs Commonwealth Co.,Ltd.26,41131%
Biomet Spine Llc24,16728%
Gs Medical Co., Ltd.5,4436%
Choice Spine, Lp2,8483%
Orthofix Us Llc2,1833%
Diomedical Co.,Ltd.1,6402%
Seaspine Orthopedics Corporation1,5652%
Corelink Llc1,5312%

Top labelers

CompanyDevicesShare
Gbs Commonwealth Co.,Ltd.26,41131%
Biomet Spine Llc24,16728%
Gs Medical Co., Ltd.5,4436%
Choice Spine, Lp2,8483%
Orthofix Us Llc2,1833%
Diomedical Co.,Ltd.1,6402%
Seaspine Orthopedics Corporation1,5652%
Corelink Llc1,5312%
Genesys Orthopedics Systems Llc1,4982%
Zimmer Spine, Inc.1,3972%
Degen Medical, Inc.1,3782%
Spinal Elements, Inc.1,3242%

Company = labeler of record on GUDID. 65 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Planar ScrewMulti-Axial Reduction ScrewPlanar Reduction ScrewTI rod 6x250mm cvd.TI rod 6x200mm cvd.TI rod 6x180mm cvd.TI rod 6x160mm cvd.TI rod 6x140mm cvd.TI rod 6x120mm cvd.TI rod 6x110mm cvd.TI rod 6x100mm cvd.TI rod 6x90mm cvd.TI rod 6x80mm cvd.TI rod 6x70mm cvd.TI rod 6x60mm cvd.TI rod 6x55mm cvd.

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

FDA product codes

CodeNameDevices
NKBThoracolumbosacral Pedicle Screw System33,863
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL30,471
MNHOrthosis, spondylolisthesis spinal fixation28,736
MNIORTHOSIS, SPINAL PEDICLE FIXATION20,862
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis16,434
MNIOrthosis, Spinal Pedicle Fixation15,425

GMDN & GCC registration

  • GMDN code 61325 · non‑implantable
  • Single‑use 96% · sterile 1% · Rx‑only 67% · 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) · 13,796Outer Diameter (Millimeter) · 10,951Height (Millimeter) · 414Width (Millimeter) · 256Angle (degree) · 150Lumen/Inner Diameter (Millimeter) · 96

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

How many bone-screw internal spinal fixation system, non-sterile products are registered in the US?

85,917 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone-screw internal spinal fixation system, non-sterile", from 65 companies. The largest labeler is Gbs Commonwealth Co.,Ltd. with 31% of records.

Which FDA product codes apply?

NKB (Thoracolumbosacral Pedicle Screw System), KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), MNH (Orthosis, spondylolisthesis spinal fixation), MNI (ORTHOSIS, SPINAL PEDICLE FIXATION)

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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