Consulting Wallah › Device Explorer › Orthopaedic implants › Spinal bone screw head/rod adaptor
Device Explorer · FDA GUDID · GMDN 66948

Spinal bone screw head/rod adaptor

A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tuli

US‑registered devices133in commercial distribution
Companies20labelers on GUDID
Single‑use92%of device records
Sterile11%labelled sterile
Prescription96%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Precision Spine, Inc.2720%
Signus Medizintechnik Gmbh1411%
Nexxt Spine, Llc129%
Alphatec Spine, Inc.108%
Biedermann Motech Gmbh & Co. Kg86%
S.M.A.I.O86%
Zavation Llc86%
Life Spine, Inc.65%

Top labelers

CompanyDevicesShare
Precision Spine, Inc.2720%
Signus Medizintechnik Gmbh1411%
Nexxt Spine, Llc129%
Alphatec Spine, Inc.108%
Biedermann Motech Gmbh & Co. Kg86%
S.M.A.I.O86%
Zavation Llc86%
Life Spine, Inc.65%
Xenix Medical Llc54%
Cg Medtech Co.,Ltd.54%
Spine Wave, Inc.43%
Carbofix Orthopedics Ltd32%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CarboClear Pedicle Screw SystemTitamed Spinal SystemNADIPLOMATKHEIRONInertia® CONNEXX™ Modular Pedicle Screw SystemCore Lumbar Fixation SystemTAURUS Pedicle Screw SystemSEURAT Universal Pedicle Screw SystemRIVA Posterior Fixation SystemReform® Ti CT Modular MIS Pedicle Screw SystemReform Ti ModularReform Ti CT Modular MIS Pedicle Screw SystemReform Midline Cortical Screw SystemReform® Ti ModularZAVATION MODULAR MIS HEAD ASSEMBLY

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 System74
MNIOrthosis, Spinal Pedicle Fixation42
MNHOrthosis, Spondylolisthesis Spinal Fixation42
KWPAppliance, Fixation, Spinal Interlaminal28
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Dis26
NKBThoracolumbosacral pedicle screw system25

GMDN & GCC registration

  • GMDN code 66948 · implantable
  • Single‑use 92% · sterile 11% · Rx‑only 96% · 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

Outer Diameter (Millimeter) · 7Length (Millimeter) · 4

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

How many spinal bone screw head/rod adaptor products are registered in the US?

133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal bone screw head/rod adaptor", from 20 companies. The largest labeler is Precision Spine, Inc. with 20% of records.

Which FDA product codes apply?

NKB (Thoracolumbosacral Pedicle Screw System), MNI (Orthosis, Spinal Pedicle Fixation), MNH (Orthosis, Spondylolisthesis Spinal Fixation), KWP (Appliance, Fixation, Spinal Interlaminal)

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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