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Device Explorer · FDA GUDID · GMDN 65116

Bone-screw internal spinal fixation system rod

An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an

US‑registered devices37,835in commercial distribution
Companies98labelers on GUDID
Single‑use88%of device records
Sterile12%labelled sterile
Prescription71%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Nuvasive, Inc.4,39612%
L&K Biomed Co. ,Ltd.4,38812%
Gbs Commonwealth Co.,Ltd.2,7417%
Medtronic Sofamor Danek, Inc.1,8255%
Medyssey Co., Ltd.1,5514%
Alphatec Spine, Inc.1,5404%
Seaspine Orthopedics Corporation1,3294%
Highridge Medical, Llc1,3103%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.4,39612%
L&K Biomed Co. ,Ltd.4,38812%
Gbs Commonwealth Co.,Ltd.2,7417%
Medtronic Sofamor Danek, Inc.1,8255%
Medyssey Co., Ltd.1,5514%
Alphatec Spine, Inc.1,5404%
Seaspine Orthopedics Corporation1,3294%
Highridge Medical, Llc1,3103%
Next Orthosurgical, Inc.1,2663%
Vb Spine Llc1,1543%
Xenix Medical Llc9292%
Cg Medtech Co.,Ltd.8892%

Company = labeler of record on GUDID. 98 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OASYSXIA 4.5 Spinal SystemES2 SPINAL SYSTEMXIA 4 5XIA 3RADIUSMANTISXIA IICarboClear Posterior Cervical Screw SystemCarboClear Pedicle Screw SystemsPER System 50PER System 75PER System 60ProMIS™ Fixation SystemPER Set Screw TorxPER Ring Nut

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

FDA product codes

CodeNameDevices
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL14,884
MNHOrthosis, spondylolisthesis spinal fixation10,780
NKBThoracolumbosacral Pedicle Screw System10,274
MNIORTHOSIS, SPINAL PEDICLE FIXATION9,601
MNIOrthosis, Spinal Pedicle Fixation9,510
MNHOrthosis, Spondylolisthesis Spinal Fixation9,504

GMDN & GCC registration

  • GMDN code 65116 · implantable
  • Single‑use 88% · sterile 12% · Rx‑only 71% · 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) · 9,218Outer Diameter (Millimeter) · 7,619Angle (degree) · 183Length (Centimeter) · 66Width (Millimeter) · 49Length (Inch) · 7

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

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

37,835 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 rod", from 98 companies. The largest labeler is Nuvasive, Inc. with 12% of records.

Which FDA product codes apply?

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