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Device Explorer · FDA GUDID · GMDN 44797

Internal spinal fixation system cable

An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of

US‑registered devices82in commercial distribution
Companies11labelers on GUDID
Single‑use90%of device records
Sterile66%labelled sterile
Prescription85%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Pioneer Surgical Technology, Inc.3745%
Medtronic Sofamor Danek, Inc.1012%
Vb Spine Llc1012%
Nuvasive, Inc.67%
Alphatec Spine, Inc.56%
Synthes Gmbh45%
Medos International Sàrl34%
Depuy Spine, Llc34%

Top labelers

CompanyDevicesShare
Pioneer Surgical Technology, Inc.3745%
Medtronic Sofamor Danek, Inc.1012%
Vb Spine Llc1012%
Nuvasive, Inc.67%
Alphatec Spine, Inc.56%
Synthes Gmbh45%
Medos International Sàrl34%
Depuy Spine, Llc34%
Spinal Elements, Inc.22%
Cousin Biotech11%
Implanet11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ResCUBE™JAZZ SystemVersaTieKARMASpine Cable SystemSonger® Spinal Cable SystemATLAS® Cable SystemInvictusNILE™ Alternative Fixation SystemNAEXPEDIUMISOLA

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JDQCERCLAGE, FIXATION53
JDQCerclage, fixation39
JDQCerclage, Fixation30
OWIBone fixation cerclage, sublaminar21
LRNWire, surgical10
OWIBone Fixation Cerclage, Sublaminar4

GMDN & GCC registration

  • GMDN code 44797 · implantable
  • Single‑use 90% · sterile 66% · Rx‑only 85% · 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) · 10Width (Millimeter) · 4Length (Millimeter) · 2

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

How many internal spinal fixation system cable products are registered in the US?

82 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal spinal fixation system cable", from 11 companies. The largest labeler is Pioneer Surgical Technology, Inc. with 45% of records.

Which FDA product codes apply?

JDQ (CERCLAGE, FIXATION), JDQ (Cerclage, fixation), JDQ (Cerclage, Fixation), OWI (Bone fixation cerclage, sublaminar)

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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