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Device Explorer · FDA GUDID · GMDN 65115

Bone-screw internal spinal fixation system hook

An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also us

US‑registered devices4,297in commercial distribution
Companies44labelers on GUDID
Single‑use86%of device records
Sterile7%labelled sterile
Prescription74%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Nuvasive, Inc.61014%
Alphatec Spine, Inc.56213%
Gbs Commonwealth Co.,Ltd.47911%
Medtronic Sofamor Danek, Inc.3378%
Medyssey Co., Ltd.3308%
Vb Spine Llc3298%
Medos International Sàrl1864%
L&K Biomed Co. ,Ltd.1604%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.61014%
Alphatec Spine, Inc.56213%
Gbs Commonwealth Co.,Ltd.47911%
Medtronic Sofamor Danek, Inc.3378%
Medyssey Co., Ltd.3308%
Vb Spine Llc3298%
Medos International Sàrl1864%
L&K Biomed Co. ,Ltd.1604%
Spinecraft, Llc1463%
Highridge Medical, Llc1403%
Seaspine Orthopedics Corporation1333%
Synthes Gmbh1173%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

XIA 3HookHook 5.5Reduction Pedicle HookOffset HookNarrow Transverse Process HookNarrow Lamina HookNarrow Pedicle HookWide Transverse Process HookWide Lamina HookWide Pedicle HookTransverse Process HookLamina HookPedicle HookTitamed Spinal SystemVertefix II

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 INTERLAMINAL2,938
MNHOrthosis, spondylolisthesis spinal fixation1,963
MNIORTHOSIS, SPINAL PEDICLE FIXATION1,873
NKBOrthosis, spinal pedicle fixation, for degenerative disc dis1,550
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1,354
NKBThoracolumbosacral pedicle screw system1,012

GMDN & GCC registration

  • GMDN code 65115 · implantable
  • Single‑use 86% · sterile 7% · Rx‑only 74% · 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) · 360Height (Millimeter) · 259Width (Millimeter) · 218Lumen/Inner Diameter (Millimeter) · 142Length (Millimeter) · 130Angle (degree) · 89

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

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

4,297 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 hook", from 44 companies. The largest labeler is Nuvasive, Inc. with 14% of records.

Which FDA product codes apply?

KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL), MNH (Orthosis, spondylolisthesis spinal fixation), MNI (ORTHOSIS, SPINAL PEDICLE FIXATION), NKB (Orthosis, spinal pedicle fixation, for degenerative disc dis)

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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