Consulting Wallah › Device Explorer › Orthopaedic implants › Spinal bone screw, non-bioabsorbable
Device Explorer · FDA GUDID · GMDN 46651

Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically d

US‑registered devices181,223in commercial distribution
Companies139labelers on GUDID
Single‑use91%of device records
Sterile12%labelled sterile
Prescription79%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Alphatec Spine, Inc.19,11211%
L&K Biomed Co. ,Ltd.15,3398%
Nuvasive, Inc.14,6658%
Medtronic Sofamor Danek, Inc.13,2157%
Cg Medtech Co.,Ltd.12,4907%
Highridge Medical, Llc8,4695%
Medyssey Co., Ltd.7,4784%
Astura Medical7,0034%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.19,11211%
L&K Biomed Co. ,Ltd.15,3398%
Nuvasive, Inc.14,6658%
Medtronic Sofamor Danek, Inc.13,2157%
Cg Medtech Co.,Ltd.12,4907%
Highridge Medical, Llc8,4695%
Medyssey Co., Ltd.7,4784%
Astura Medical7,0034%
Spinecraft, Llc5,7213%
Vb Spine Llc5,6463%
Bk Meditech Co.,Ltd.4,8563%
Alpha Ai Co.,Ltd.4,6933%

Company = labeler of record on GUDID. 139 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XIA 4.5 Spinal SystemXia 3 System - SerratoXIA 4.5 System - XIA CTOASYSXIA 3XIA 4.5ES2 SPINAL SYSTEMXIA 4 5XIA IICarboClear Hybrid Pedicle Screw SystemCarboClear Modular Hybrid Pedicle Screw SystemCarboClear Posterior Cervical Screw SystemCarboClear X Pedicle Screw SystemCannulated Tapered Pedicle ScrewCannulated Tapered Polyaxial Pedicle ScrewNon-Cannulated Polyaxial Pedicle Screw

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 INTERLAMINAL76,853
MNHOrthosis, spondylolisthesis spinal fixation52,898
NKBThoracolumbosacral pedicle screw system49,798
NKBThoracolumbosacral Pedicle Screw System46,325
MNIORTHOSIS, SPINAL PEDICLE FIXATION43,123
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis34,956

GMDN & GCC registration

  • GMDN code 46651 · implantable
  • Single‑use 91% · sterile 12% · Rx‑only 79% · 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) · 60,072Outer Diameter (Millimeter) · 50,943Width (Millimeter) · 2,375Angle (degree) · 1,100Lumen/Inner Diameter (Millimeter) · 347Circumference (Millimeter) · 154

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

How many spinal bone screw, non-bioabsorbable products are registered in the US?

181,223 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal bone screw, non-bioabsorbable", from 139 companies. The largest labeler is Alphatec Spine, Inc. with 11% of records.

Which FDA product codes apply?

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

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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