Consulting Wallah › Device Explorer › Other devices › Bone/joint surgical power tool motorized handpiece
Device Explorer · FDA GUDID · GMDN 58189

Bone/joint surgical power tool motorized handpiece/set, pneumatic

A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedur

US‑registered devices88in commercial distribution
Companies11labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Imedicom Co., Ltd.2124%
Aesculap Ag2023%
Microaire Surgical Instruments Llc1618%
Conmed Corporation1112%
De Soutter Medical Limited56%
Peter Brasseler Holdings, Llc56%
Stryker Corporation45%
Zethon Limited22%

Top labelers

CompanyDevicesShare
Imedicom Co., Ltd.2124%
Aesculap Ag2023%
Microaire Surgical Instruments Llc1618%
Conmed Corporation1112%
De Soutter Medical Limited56%
Peter Brasseler Holdings, Llc56%
Stryker Corporation45%
Zethon Limited22%
Adeor Medical Ag22%
Synthes Gmbh11%
Imt Integral Medizintechnik Ag11%

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

Brand names on the register (sample)

Maestro AirCOREMaestroZethonDe Soutter MedicalCORE, MaestroVELOCITY ALPHA ™ELAN 4AESCULAPMICROLAN 100Brasseler USAMicroAire®NAMICRO 100CONMEDPOWERPRO

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

FDA product codes

CodeNameDevices
GETMotor, Surgical Instrument, Pneumatic Powered27
HBBMOTOR, DRILL, PNEUMATIC24
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)18
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Access11
HSZInstrument, surgical, orthopedic, pneumatic powered & access7
HTZINSTRUMENT, CUTTING, ORTHOPEDIC6

GMDN & GCC registration

  • GMDN code 58189 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 68% · 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 bone/joint surgical power tool motorized handpiece/set, pneumatic products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone/joint surgical power tool motorized handpiece/set, pneumatic", from 11 companies. The largest labeler is Imedicom Co., Ltd. with 24% of records.

Which FDA product codes apply?

GET (Motor, Surgical Instrument, Pneumatic Powered), HBB (MOTOR, DRILL, PNEUMATIC), HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Access)

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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