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Device Explorer · FDA GUDID · GMDN 55851

Flexible intramedullary nail

A bendable metallic rod intended to be implanted into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fr

US‑registered devices152in commercial distribution
Companies8labelers on GUDID
Single‑use99%of device records
Sterile38%labelled sterile
Prescription87%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Epix Orthopaedics Inc.6039%
Stryker Gmbh3221%
Meduloc, Llc2013%
Synthes Gmbh1812%
Orthofix Srl96%
Flower Orthopedics Corporation64%
Auxein Medical Private Limited64%
Neoortho Produtos Ortopédicos S/A.11%

Top labelers

CompanyDevicesShare
Epix Orthopaedics Inc.6039%
Stryker Gmbh3221%
Meduloc, Llc2013%
Synthes Gmbh1812%
Orthofix Srl96%
Flower Orthopedics Corporation64%
Auxein Medical Private Limited64%
Neoortho Produtos Ortopédicos S/A.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2Fibula Nail, 5.5mm x 180mm, Titanium, Flex-ThreaFibula Nail, 5.5mm x 130mm, Titanium, Flex-ThreaFibula Nail, 4.5mm x 180mm, Titanium, Flex-ThreaFibula Nail, 4.5mm x 130mm, Titanium, Flex-ThreaFibula Nail, 3.5mm x 180mm, Titanium, Flex-ThreaFibula Nail, 3.5mm x 130mm, Titanium, Flex-ThreaMeduloc Intramedullary Fracture Fixation (IFF) SEPIX Distal Screw 120.0mm x 5mmEPIX Distal Screw 110.0mm x 5mmEPIX Distal Screw 100.0mm x 5mmEPIX Distal Screw 90.0mm x 5mmEPIX Distal Screw 85.0mm x 5mmEPIX Distal Screw 80.0mm x 5mmEPIX Distal Screw 75.0mm x 5mmEPIX Distal Screw 70.0mm x 5mm

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 ACCESSORIES106
JDWPin, Fixation, Threaded20
HTYPIN, FIXATION, SMOOTH10
HWCScrew, Fixation, Bone9
JDSNail, Fixation, Bone6
FZXGuide, Surgical, Instrument1

GMDN & GCC registration

  • GMDN code 55851 · implantable
  • Single‑use 99% · sterile 38% · 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

Length (Millimeter) · 105Outer Diameter (Millimeter) · 15

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

How many flexible intramedullary nail products are registered in the US?

152 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Flexible intramedullary nail", from 8 companies. The largest labeler is Epix Orthopaedics Inc. with 39% of records.

Which FDA product codes apply?

HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES), JDW (Pin, Fixation, Threaded), HTY (PIN, FIXATION, SMOOTH), HWC (Screw, Fixation, Bone)

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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