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Device Explorer · FDA GUDID · GMDN 65553

Spinal bone set screw

A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether

US‑registered devices453in commercial distribution
Companies65labelers on GUDID
Single‑use93%of device records
Sterile17%labelled sterile
Prescription81%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

L&K Biomed Co. ,Ltd.368%
Medos International Sàrl348%
Alphatec Spine, Inc.256%
Seaspine Orthopedics Corporation245%
Signus Medizintechnik Gmbh225%
Medacta International Sa225%
Highridge Medical, Llc215%
Depuy Spine, Llc215%

Top labelers

CompanyDevicesShare
L&K Biomed Co. ,Ltd.368%
Medos International Sàrl348%
Alphatec Spine, Inc.256%
Seaspine Orthopedics Corporation245%
Signus Medizintechnik Gmbh225%
Medacta International Sa225%
Highridge Medical, Llc215%
Depuy Spine, Llc215%
Synthes Gmbh204%
Spine Wave, Inc.174%
Gbs Commonwealth Co.,Ltd.153%
Spinecraft, Llc143%

Company = labeler of record on GUDID. 65 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CarboClear Posterior Cervical Screw SystemCarboClear Hybrid Pedicle Screw SystemCarboClear X Pedicle Screw SystemVertefixNOVA Minimally Invasive SystemFacilis™ Spinal SystemTREND II Spinal Fixation System- STEP SeriesNAVERTICALECOSYMONOPOLY/CONKLUSIONDIPLOMATCONKLUSIONMONOPOLYKHEIRONErisma®-LP

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 INTERLAMINAL152
MNHOrthosis, spondylolisthesis spinal fixation139
MNIORTHOSIS, SPINAL PEDICLE FIXATION127
NKBThoracolumbosacral Pedicle Screw System102
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis99
MNIOrthosis, Spinal Pedicle Fixation94

GMDN & GCC registration

  • GMDN code 65553 · implantable
  • Single‑use 93% · sterile 17% · Rx‑only 81% · 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) · 7Outer Diameter (Millimeter) · 6Height (Millimeter) · 1Width (Millimeter) · 1

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

How many spinal bone set screw products are registered in the US?

453 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal bone set screw", from 65 companies. The largest labeler is L&K Biomed Co. ,Ltd. with 8% of records.

Which FDA product codes apply?

KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), MNH (Orthosis, spondylolisthesis spinal fixation), MNI (ORTHOSIS, SPINAL PEDICLE FIXATION), 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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