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Device Explorer · FDA GUDID · GMDN 46139

Bone nail implantable cap

A small, implantable, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extrac

US‑registered devices833in commercial distribution
Companies30labelers on GUDID
Single‑use99%of device records
Sterile71%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Biomet Orthopedics, Llc13316%
Synthes Gmbh10212%
Orthopediatrics Corp.9912%
Stryker Gmbh8210%
Orthofix Srl658%
Zimmer, Inc.466%
Nuvasive Specialized Orthopedics, Inc.314%
Tdm Co., Ltd.304%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc13316%
Synthes Gmbh10212%
Orthopediatrics Corp.9912%
Stryker Gmbh8210%
Orthofix Srl658%
Zimmer, Inc.466%
Nuvasive Specialized Orthopedics, Inc.314%
Tdm Co., Ltd.304%
Auxein Medical Private Limited273%
Jeil Medical Corporation243%
Orthoxel Designated Activity Company213%
Citieffe Srl213%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2GAMMAT2 ALPHAAPEXSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMFREE GLIDING SCFE SCREW SYSTEMGAP ENDO-EXO MEDULLARY SYSTEMPiccolo Composite Nailing SystemEnd Cap for Universal Tibial Nail IIUniversal End Cap for PFN/UFN/UTNApexNAORTHO SOLUTIONS SUCCESSION AFN SYSTEMOXFORD ANKLE FUSION NAIL(AFN) SYSTEMTRIGENPhantom Hindfoot TTC/TC Nail System

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 ACCESSORIES504
HSBRod, Fixation, Intramedullary And Accessories299
HWCScrew, fixation, bone85
JDSNAIL, FIXATION, BONE70
JDSNail, Fixation, Bone60
JDTCap, Bone16

GMDN & GCC registration

  • GMDN code 46139 · implantable
  • Single‑use 99% · sterile 71% · Rx‑only 98% · 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) · 96Outer Diameter (Millimeter) · 92Height (Millimeter) · 23Length (Micrometer) · 1

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

How many bone nail implantable cap products are registered in the US?

833 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone nail implantable cap", from 30 companies. The largest labeler is Biomet Orthopedics, Llc with 16% of records.

Which FDA product codes apply?

HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES), HSB (Rod, Fixation, Intramedullary And Accessories), HWC (Screw, fixation, bone), JDS (NAIL, 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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