Consulting Wallah › Device Explorer › Other devices › Bone tap, single-use, non-sterile
Device Explorer · FDA GUDID · GMDN 47562

Bone tap, single-use, non-sterile

A non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainle

US‑registered devices81in commercial distribution
Companies7labelers on GUDID
Single‑use93%of device records
Sterile6%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc3543%
Biomet Microfixation, Inc2328%
Advanced Orthopaedic Solutions, Inc.1316%
Osteomed Llc45%
Fusion Orthopedics, Llc34%
Southern Implants (Pty) Ltd22%
Flospine Llc11%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc3543%
Biomet Microfixation, Inc2328%
Advanced Orthopaedic Solutions, Inc.1316%
Osteomed Llc45%
Fusion Orthopedics, Llc34%
Southern Implants (Pty) Ltd22%
Flospine Llc11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/ATraumaOne SYSTEMLACTOSORB® SYSTEMLACTOSORB® 2.0MM SYSTEMCANNULATED CANCELLOUS TAPCANNULATED CORTICAL TAPLOCKING CORTICAL TAPSOLID CANCELLOUS TAPTAP, CANCELLOUS, CANNULATED, S-COUPLETAP, CORTICAL, SOLID, S-COUPLETAP, CANCELLOUS, SOLID, S-COUPLETHP™ Hip Fracture Plating SystemORTHOSORB LS2.0 mm STRAIGHT PIN KIT, 1 PINTSP HIP FX PLATING SYSTEM7.5MM TAPSOLID CORTICAL TAPLAG SCREW TAP

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

FDA product codes

CodeNameDevices
HWXTAP, BONE43
LXHOrthopedic Manual Surgical Instrument13
JEYPLATE, BONE8
HTWBIT, DRILL7
HWCScrew, fixation, bone6
HWKTREPHINE3

GMDN & GCC registration

  • GMDN code 47562 · non‑implantable
  • Single‑use 93% · sterile 6% · Rx‑only 100% · 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) · 7Length (Millimeter) · 3

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

How many bone tap, single-use, non-sterile products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone tap, single-use, non-sterile", from 7 companies. The largest labeler is Biomet Orthopedics, Llc with 43% of records.

Which FDA product codes apply?

HWX (TAP, BONE), LXH (Orthopedic Manual Surgical Instrument), JEY (PLATE, BONE), HTW (BIT, DRILL)

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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