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Device Explorer · FDA GUDID · GMDN 32859

Orthopaedic bone screw starter/notcher

A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, m

US‑registered devices220in commercial distribution
Companies32labelers on GUDID
Single‑use14%of device records
Sterile5%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Nuvasive, Inc.3415%
Degen Medical, Inc.2511%
Steris Corporation2310%
Osteomed Llc2110%
Life Spine, Inc.209%
Ldr Spine Usa, Inc.125%
Biopro, Inc.125%
Fusion Orthopedics, Llc84%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.3415%
Degen Medical, Inc.2511%
Steris Corporation2310%
Osteomed Llc2110%
Life Spine, Inc.209%
Ldr Spine Usa, Inc.125%
Biopro, Inc.125%
Fusion Orthopedics, Llc84%
Medtronic Sofamor Danek, Inc.84%
Highridge Medical, Llc52%
Ascension Orthopedics, Inc.52%
Ortho-Design (Pty) Ltd42%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Activa InstrumentVersaPEEK Tapping ToolDoubleTapVersaPEEK TapNAIBS™The Tether Vertebral Body Tethering SystemSpineTune TLGeneral instrumentationEasyspineArthrex®Gentle Threads™ReLineArmadaVuePointJUGGERKNOT PUNCH

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

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT52
LXHOrthopedic manual surgical instrument30
HWCScrew, fixation, bone25
HTWBIT, DRILL25
HWDSTARTER, BONE SCREW23
NKBThoracolumbosacral pedicle screw system20

GMDN & GCC registration

  • GMDN code 32859 · non‑implantable
  • Single‑use 14% · sterile 5% · Rx‑only 95% · 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) · 24

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

How many orthopaedic bone screw starter/notcher products are registered in the US?

220 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone screw starter/notcher", from 32 companies. The largest labeler is Nuvasive, Inc. with 15% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), HWC (Screw, fixation, 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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