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Device Explorer · FDA GUDID · GMDN 61929

Orthopaedic implant aiming/guiding block attachment tool

A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.

US‑registered devices239in commercial distribution
Companies16labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Synthes Gmbh9339%
Aap Implantate Ag5322%
Depuy Spine, Llc2611%
Microport Orthopedics Inc.177%
Trimed, Inc.167%
Forma Medical, Inc.104%
Skeletal Dynamics L.L.C.73%
Premia Spine Ltd52%

Top labelers

CompanyDevicesShare
Synthes Gmbh9339%
Aap Implantate Ag5322%
Depuy Spine, Llc2611%
Microport Orthopedics Inc.177%
Trimed, Inc.167%
Forma Medical, Inc.104%
Skeletal Dynamics L.L.C.73%
Premia Spine Ltd52%
Paragon 28, Inc.42%
Alphatec Spine, Inc.21%
Alphamet Ltd10%
Expanding Innovations, Inc.10%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Counter Torque PERMIS Tower GuideTOPS Loading BaseTower Guide STRing Nut Loading BaseCyclaPlex Drill GuideLOQTEQ®NABaby Gorilla®/Gorilla® Plating SystemPhantom Hindfoot TTC/TC Nail SystemGorilla Plating SystemX-PACTools - WS3Tools - DHFTools - WFS (C)Tools - WFS

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 INSTRUMENT107
FZXGuide, surgical, instrument79
HWTTEMPLATE19
HWCScrew, fixation, bone16
HRSPlate, fixation, bone14
HRSPLATE, FIXATION, BONE13

GMDN & GCC registration

  • GMDN code 61929 · non‑implantable
  • Single‑use 4% · 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

No structured size data on the register.

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

How many orthopaedic implant aiming/guiding block attachment tool products are registered in the US?

239 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 attachment tool", from 16 companies. The largest labeler is Synthes Gmbh with 39% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, surgical, instrument), HWT (TEMPLATE), HWC (Screw, fixation, bone)

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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