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Device Explorer · FDA GUDID · GMDN 45981

Hard/soft-tissue ultrasonic surgical system

An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be inten

US‑registered devices389in commercial distribution
Companies10labelers on GUDID
Single‑use59%of device records
Sterile51%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Satelec9324%
Orthofix Srl8321%
Radley Scientific Limited7519%
W & H Dentalwerk Bürmoos Gmbh5213%
Peter Brasseler Holdings, Llc5213%
Smtp Medical Co., Ltd.236%
Trice Medical, Inc.62%
Biomet Orthopedics, Llc31%

Top labelers

CompanyDevicesShare
Satelec9324%
Orthofix Srl8321%
Radley Scientific Limited7519%
W & H Dentalwerk Bürmoos Gmbh5213%
Peter Brasseler Holdings, Llc5213%
Smtp Medical Co., Ltd.236%
Trice Medical, Inc.62%
Biomet Orthopedics, Llc31%
Misonix, Inc.10%
Synthes Gmbh10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SMTPTORSACTEONSATELECULTRA DRIVE III SETULTRA DRIVE III HANDPIECEULTRA DRIVE III CONSOLETenex 2nd Generation Fuse SetTenex 2nd Generation ConsoleTenex 2nd Generation MicroTip, TXS+, 1.3 WLTenex 2nd Generation MicroTip, TXS, 2.0 WLTenex 2nd Generation MicroTip, TXL+, 2.5 WLTenex 2nd Generation MicroTip, TXL, 3.0 WLBoneScalpelOSCAR PROOSCAR 3

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

FDA product codes

CodeNameDevices
JDXInstrument, Surgical, Sonic And Accessory/Attachment303
LZVSystem, cement removal extraction54
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handp52
DZIDrill, Bone, Powered52
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces52
LZVSystem, Cement Removal Extraction50

GMDN & GCC registration

  • GMDN code 45981 · non‑implantable
  • Single‑use 59% · sterile 51% · 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

Length (Millimeter) · 101Outer Diameter (Millimeter) · 75Width (Millimeter) · 12Length (Meter) · 1Lumen/Inner Diameter (Millimeter) · 1

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

How many hard/soft-tissue ultrasonic surgical system products are registered in the US?

389 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hard/soft-tissue ultrasonic surgical system", from 10 companies. The largest labeler is Satelec with 24% of records.

Which FDA product codes apply?

JDX (Instrument, Surgical, Sonic And Accessory/Attachment), LZV (System, cement removal extraction), ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handp), DZI (Drill, Bone, Powered)

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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