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Device Explorer · FDA GUDID · GMDN 47847

Orthopaedic implant-instrument extension adaptor, reusable

A connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure fo

US‑registered devices1,318in commercial distribution
Companies75labelers on GUDID
Single‑use6%of device records
Sterile3%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc19114%
Smith & Nephew, Inc.826%
United Orthopedic Corp.806%
Zimmer, Inc.705%
Implantcast Gmbh584%
Corin Ltd564%
Stryker Gmbh494%
Alphatec Spine, Inc.463%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc19114%
Smith & Nephew, Inc.826%
United Orthopedic Corp.806%
Zimmer, Inc.705%
Implantcast Gmbh584%
Corin Ltd564%
Stryker Gmbh494%
Alphatec Spine, Inc.463%
Ortho Development Corporation453%
Synthes Gmbh423%
Silony Medical Gmbh413%
Depuy (Ireland)413%

Company = labeler of record on GUDID. 75 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2GAMMAT2 ALPHAXia 3 System - SerratoINSTRUMENTN/AOASYSXIA 4.5 System - XIA CTOMEGAHOFFMANNAXSOSNATC-PLUS Revision / RT-PLUSPOLARCUPPROMOSSL-PLUS

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 INSTRUMENT332
LXHOrthopedic Manual Surgical Instrument200
LXHOrthopedic manual surgical instrument153
HTOReamer44
KXAProsthesis, hip, femoral, resurfacing38
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT36

GMDN & GCC registration

  • GMDN code 47847 · non‑implantable
  • Single‑use 6% · sterile 3% · Rx‑only 80% · 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) · 14Outer Diameter (Millimeter) · 10Lumen/Inner Diameter (Millimeter) · 3Length (Feet) · 1Height (Millimeter) · 1Width (Millimeter) · 1

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

How many orthopaedic implant-instrument extension adaptor, reusable products are registered in the US?

1,318 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant-instrument extension adaptor, reusable", from 75 companies. The largest labeler is Biomet Orthopedics, Llc with 14% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument), LXH (Orthopedic manual surgical instrument), HTO (Reamer)

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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