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Device Explorer · FDA GUDID · GMDN 35559

Bone file/rasp, manual, reusable

A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part o

US‑registered devices8,517in commercial distribution
Companies194labelers on GUDID
Single‑use5%of device records
Sterile1%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.5987%
Seaspine Orthopedics Corporation5206%
Spineup, Inc.4816%
Highridge Medical, Llc4635%
Biomet Orthopedics, Llc3264%
Kalitec Direct Llc2903%
Alphatec Spine, Inc.2893%
Medicon Eg. Chirurgiemechaniker-Genossenschaft2483%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.5987%
Seaspine Orthopedics Corporation5206%
Spineup, Inc.4816%
Highridge Medical, Llc4635%
Biomet Orthopedics, Llc3264%
Kalitec Direct Llc2903%
Alphatec Spine, Inc.2893%
Medicon Eg. Chirurgiemechaniker-Genossenschaft2483%
Avalign Technologies, Inc.2203%
Synthes Gmbh1932%
Nexus Spine, L.L.C.1682%
Zimmer, Inc.1592%

Company = labeler of record on GUDID. 194 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NATritanium CPosterior TLIFENDOTRACINSTRUMENTRELIANCE CRELIANCE ALRELIANCERELIANCE LITeX-FUSESMART TOEPOLARSTEMSL-PLUSSLR-PLUS'SL-PLUS¿'Osteotec Silicone Finger - Proximal Rasp Size 9

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

FDA product codes

CodeNameDevices
HTRRASP2,314
HTRRasp886
LXHOrthopedic Manual Surgical Instrument859
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT562
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY477
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, ce417

GMDN & GCC registration

  • GMDN code 35559 · non‑implantable
  • Single‑use 5% · sterile 1% · Rx‑only 83% · 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

Height (Millimeter) · 1,339Width (Millimeter) · 1,250Depth (Millimeter) · 734Length (Millimeter) · 481Angle (degree) · 474Length (Inch) · 175

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

How many bone file/rasp, manual, reusable products are registered in the US?

8,517 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone file/rasp, manual, reusable", from 194 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 7% of records.

Which FDA product codes apply?

HTR (RASP), HTR (Rasp), 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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