Consulting Wallah › Device Explorer › Other devices › Orthopaedic bone bolt
Device Explorer · FDA GUDID · GMDN 16077

Orthopaedic bone bolt

A short, implantable rod or shaft designed to be inserted through a long bone (excludes spinal bone) to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It i

US‑registered devices200in commercial distribution
Companies11labelers on GUDID
Single‑use94%of device records
Sterile30%labelled sterile
Prescription87%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Synthes Gmbh10552%
Orthopediatrics Corp.5427%
Ortho Outcomes, Llc2312%
Flow-Fx105%
Depuy Orthopaedics, Inc.21%
Smith & Nephew, Inc.10%
Fusion Orthopedics, Llc10%
Hnm Total Recon Llc10%

Top labelers

CompanyDevicesShare
Synthes Gmbh10552%
Orthopediatrics Corp.5427%
Ortho Outcomes, Llc2312%
Flow-Fx105%
Depuy Orthopaedics, Inc.21%
Smith & Nephew, Inc.10%
Fusion Orthopedics, Llc10%
Hnm Total Recon Llc10%
Interventional Spine, Inc10%
Panther Orthopedics, Inc.10%
Medartis Ag10%

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

Brand names on the register (sample)

LEGIONRESCUE DRIVER, 5.0mm HEX, JACOBS-HALL/TRINKLE, CDEPTH GAGE STOP, 7.0 SIZEDEPTH GAGE, REUSABLE, 7.0mmGUIDEWIRE, 2.4 x 660mm, ROUND ENDSGUIDEWIRE, 2.4 x 510mm, ROUND ENDSDRILL, 7.0mm DIA, CANNULATEDGUIDEWIRE, 3.2 x 660mm, DRILL POINTGUIDEWIRE, 3.2 x 510mm, DRILL POINTCURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm ODCURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm ODNUT SLEEVE, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEXNUT SLEEVE, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEXNUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEXNUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEXNUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX

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

FDA product codes

CodeNameDevices
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES178
JDSNAIL, FIXATION, BONE113
HWCScrew, fixation, bone92
JDWPIN, FIXATION, THREADED81
HTYPIN, FIXATION, SMOOTH54
HWCScrew, Fixation, Bone27

GMDN & GCC registration

  • GMDN code 16077 · implantable
  • Single‑use 94% · sterile 30% · Rx‑only 87% · 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

No structured size data on the register.

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

How many orthopaedic bone bolt products are registered in the US?

200 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone bolt", from 11 companies. The largest labeler is Synthes Gmbh with 52% of records.

Which FDA product codes apply?

HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES), JDS (NAIL, FIXATION, BONE), HWC (Screw, fixation, bone), JDW (PIN, FIXATION, THREADED)

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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