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Device Explorer · FDA GUDID · GMDN 63198

Orthopaedic implant aiming/guiding block, single-use

A sterile surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation pl

US‑registered devices1,764in commercial distribution
Companies3labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Mios Marketing, Llc1,74599%
Crossroads Extremity Systems181%
Wright Medical Technology, Inc.10%

Top labelers

CompanyDevicesShare
Mios Marketing, Llc1,74599%
Crossroads Extremity Systems181%
Wright Medical Technology, Inc.10%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MICAMOTOBAND CPIntelliguidesThe Better BunionTHe Better BunionThe Better bunionThe Bigger Bunion

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

FDA product codes

CodeNameDevices
PBFOrthopaedic Surgical Planning And Instrument Guides1,745
LXHOrthopedic Manual Surgical Instrument18
FZXGuide, surgical, instrument1
PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set1

GMDN & GCC registration

  • GMDN code 63198 · non‑implantable
  • Single‑use 99% · sterile 0% · 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) · 1,745Depth (Millimeter) · 1,635Angle (degree) · 95Height (Millimeter) · 1

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

How many orthopaedic implant aiming/guiding block, single-use products are registered in the US?

1,764 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant aiming/guiding block, single-use", from 3 companies. The largest labeler is Mios Marketing, Llc with 99% of records.

Which FDA product codes apply?

PBF (Orthopaedic Surgical Planning And Instrument Guides), LXH (Orthopedic Manual Surgical Instrument), FZX (Guide, surgical, instrument), PBK (Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set)

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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