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Device Explorer · FDA GUDID · GMDN 65114

Bone-screw internal spinal fixation system connector

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immo

US‑registered devices9,627in commercial distribution
Companies82labelers on GUDID
Single‑use88%of device records
Sterile10%labelled sterile
Prescription68%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Gbs Commonwealth Co.,Ltd.1,61317%
Nuvasive, Inc.95810%
L&K Biomed Co. ,Ltd.8339%
Medtronic Sofamor Danek, Inc.7358%
Alphatec Spine, Inc.4905%
Vb Spine Llc4635%
Highridge Medical, Llc4054%
Medyssey Co., Ltd.3614%

Top labelers

CompanyDevicesShare
Gbs Commonwealth Co.,Ltd.1,61317%
Nuvasive, Inc.95810%
L&K Biomed Co. ,Ltd.8339%
Medtronic Sofamor Danek, Inc.7358%
Alphatec Spine, Inc.4905%
Vb Spine Llc4635%
Highridge Medical, Llc4054%
Medyssey Co., Ltd.3614%
Medos International Sàrl3333%
Seaspine Orthopedics Corporation3043%
Depuy Spine, Llc2262%
Zavation Llc2112%

Company = labeler of record on GUDID. 82 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XIAXIA 4.5 Spinal SystemOASYSXIA 3RADIUSCarboClear Pedicle Screw SystemKangLi Pedicle Screw Spinal SystemClosed Lateral ConnectorOpen Lateral ConnectorDomino Connector 5.5/5.5Lateral Connector5.5Titamed Spinal SystemVertefixWiltrom Spinal Fixation SystemFacilis™ Spinal SystemSyntec OS Spinal Fixation System

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 INTERLAMINAL4,299
NKBThoracolumbosacral Pedicle Screw System2,756
MNHOrthosis, spondylolisthesis spinal fixation2,754
MNIORTHOSIS, SPINAL PEDICLE FIXATION2,522
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1,972
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis1,951

GMDN & GCC registration

  • GMDN code 65114 · implantable
  • Single‑use 88% · sterile 10% · Rx‑only 68% · 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) · 1,193Outer Diameter (Millimeter) · 773Width (Millimeter) · 87Circumference (Millimeter) · 58Length (Inch) · 56Angle (degree) · 49

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

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

9,627 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 connector", from 82 companies. The largest labeler is Gbs Commonwealth Co.,Ltd. with 17% of records.

Which FDA product codes apply?

KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), NKB (Thoracolumbosacral Pedicle Screw System), 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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