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Device Explorer · FDA GUDID · GMDN 47874

Orthopaedic ball spike

A hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singul

US‑registered devices81in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Synthes Gmbh1923%
Limacorporate Spa1215%
I.T.S. Gmbh911%
Stryker Gmbh810%
T.A.G Medical Products Agricultural Cooperative Association79%
Biomet Orthopedics, Llc45%
Avalign Technologies, Inc.45%
Zimmer, Inc.34%

Top labelers

CompanyDevicesShare
Synthes Gmbh1923%
Limacorporate Spa1215%
I.T.S. Gmbh911%
Stryker Gmbh810%
T.A.G Medical Products Agricultural Cooperative Association79%
Biomet Orthopedics, Llc45%
Avalign Technologies, Inc.45%
Zimmer, Inc.34%
Smith & Nephew, Inc.34%
Gsource Llc34%
Teleflex Incorporated34%
Aesculap Ag22%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PROAXSOSNASQ.LINE8MM BALL SPIKE PUSHER WITH HANDLEAlliance®Affixus®THP™ Hip Fracture Plating SystemTSP HIP FX PLATING SYSTEMREDUCTION TOOLBALL SPIKESPIKED DISCEVOSPacific InstrumentsgSourceLife InstrumentsMillennium

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 Instrument13
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement12
FZXGuide, surgical, instrument11
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT9
LXHOrthopedic manual surgical instrument9
GADRETRACTOR8

GMDN & GCC registration

  • GMDN code 47874 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 81% · 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

Angle (degree) · 3Length (Centimeter) · 1

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

How many orthopaedic ball spike products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic ball spike", from 15 companies. The largest labeler is Synthes Gmbh with 23% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cement), FZX (Guide, 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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