Consulting Wallah › Device Explorer › Other devices › Manual bone mill
Device Explorer · FDA GUDID · GMDN 18129

Manual bone mill

A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.

US‑registered devices197in commercial distribution
Companies46labelers on GUDID
Single‑use5%of device records
Sterile5%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Spierings Orthopaedics B.V.3116%
Kls-Martin L.P.116%
Gsource Llc105%
Medtronic Powered Surgical Solutions105%
Helmut Zepf Medizintechnik Gmbh105%
Biomet Orthopedics, Llc84%
Innomed, Inc.84%
Depuy International Ltd74%

Top labelers

CompanyDevicesShare
Spierings Orthopaedics B.V.3116%
Kls-Martin L.P.116%
Gsource Llc105%
Medtronic Powered Surgical Solutions105%
Helmut Zepf Medizintechnik Gmbh105%
Biomet Orthopedics, Llc84%
Innomed, Inc.84%
Depuy International Ltd74%
Sontec Instruments, Inc.63%
Hu-Friedy Mfg. Co., Llc63%
Osstem Implant Co., Ltd.63%
Aesculap, Inc.53%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NANeoss Implant SystemDENTECHBMT Medizintechnik GmbHKOHDENTSCHWERTReicodentdevemedAESCULAPERGOPLANTBone ManagementCROSSWAYBONE MILLGRIDCRUSHERPaul Banditt

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

FDA product codes

CodeNameDevices
LYSBone mill65
LYSBone Mill45
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT16
LXHOrthopedic Manual Surgical Instrument10
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE10
HBCMOTOR, DRILL, ELECTRIC10

GMDN & GCC registration

  • GMDN code 18129 · non‑implantable
  • Single‑use 5% · sterile 5% · Rx‑only 56% · 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 (Inch) · 1

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

How many manual bone mill products are registered in the US?

197 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual bone mill", from 46 companies. The largest labeler is Spierings Orthopaedics B.V. with 16% of records.

Which FDA product codes apply?

LYS (Bone mill), LYS (Bone Mill), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument)

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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