Consulting Wallah › Device Explorer › Other devices › Orthopaedic implantation sleeve, single-use
Device Explorer · FDA GUDID · GMDN 58148

Orthopaedic implantation sleeve, single-use

A sterile, hand-held surgical tubular device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw) and/or facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smal

US‑registered devices93in commercial distribution
Companies18labelers on GUDID
Single‑use72%of device records
Sterile42%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Fusion Orthopedics, Llc2325%
Synthes Gmbh1314%
Orthopediatrics Corp.89%
Medacta International Sa89%
Biomet Orthopedics, Llc78%
Wright Medical Technology, Inc.66%
Stryker Gmbh44%
Smith & Nephew, Inc.44%

Top labelers

CompanyDevicesShare
Fusion Orthopedics, Llc2325%
Synthes Gmbh1314%
Orthopediatrics Corp.89%
Medacta International Sa89%
Biomet Orthopedics, Llc78%
Wright Medical Technology, Inc.66%
Stryker Gmbh44%
Smith & Nephew, Inc.44%
Degen Medical, Inc.44%
Linkspine, Inc.33%
Carbofix Orthopedics Ltd22%
Arthrex, Inc.22%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2GAMMAPiccolo Composite Nailing SystemNAN/AORTHOLOCORTHOLOC™ 2 LapiFuse™SALVATIONDRILL MEASURING SLEEVEArthrex®Affixus®A.L.P.S.® Proximal Humerus Plating SystemA.L.P.S.®A.L.P.S.MEASURING DRILL SLEEVETRIGENLEGION

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 instrument20
NJAAccessory, System, External Fixator, Containing Antimicrobia15
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT13
FZXGuide, surgical, instrument8
MNIOrthosis, Spinal Pedicle Fixation8
HWCScrew, Fixation, Bone5

GMDN & GCC registration

  • GMDN code 58148 · non‑implantable
  • Single‑use 72% · sterile 42% · Rx‑only 98% · 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 implantation sleeve, single-use products are registered in the US?

93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implantation sleeve, single-use", from 18 companies. The largest labeler is Fusion Orthopedics, Llc with 25% of records.

Which FDA product codes apply?

LXH (Orthopedic manual surgical instrument), NJA (Accessory, System, External Fixator, Containing Antimicrobia), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, 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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