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Device Explorer · FDA GUDID · GMDN 67309

Spinal fixation implant/sterilization container set

A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior

US‑registered devices604in commercial distribution
Companies4labelers on GUDID
Single‑use93%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Precision Spine, Inc.53488%
Paramount Surgicals, Inc.6310%
Vy Spine Llc41%
Intelivation, Llc30%

Top labelers

CompanyDevicesShare
Precision Spine, Inc.53488%
Paramount Surgicals, Inc.6310%
Vy Spine Llc41%
Intelivation, Llc30%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

UNIMAXVyLink™VySpan™Reform TiReform Ti ModularReform Ti CT Modular MIS Pedicle Screw SystemReform Pedicle Screw SystemCap Screw Caddy KitReform POCT SystemMD-Max ULIFSure-Lok Extended Tab Pedicle Screw SystemSureLOK MIS 3LReform TIPSS SystemAccuFit ALIF Plate SystemIntervertebral Body Fusion Device

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 Interlaminal321
NKBThoracolumbosacral Pedicle Screw System288
MNHOrthosis, Spondylolisthesis Spinal Fixation187
MNIOrthosis, Spinal Pedicle Fixation187
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis70
NKBThoracolumbosacral pedicle screw system70

GMDN & GCC registration

  • GMDN code 67309 · implantable
  • Single‑use 93% · sterile 0% · Rx‑only 99% · 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) · 52Outer Diameter (Millimeter) · 12Angle (degree) · 1

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

How many spinal fixation implant/sterilization container set products are registered in the US?

604 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal fixation implant/sterilization container set", from 4 companies. The largest labeler is Precision Spine, Inc. with 88% 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.

How do I get quotes?

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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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