Consulting Wallah › Device Explorer › Orthopaedic implants › Femoral neck fixation plate/sleeve
Device Explorer · FDA GUDID · GMDN 66945

Femoral neck fixation plate/sleeve

An implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The

US‑registered devices491in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Orthopediatrics Corp.48499%
Osteocentric Technologies, Inc.61%
Zavation Llc10%

Top labelers

CompanyDevicesShare
Orthopediatrics Corp.48499%
Osteocentric Technologies, Inc.61%
Zavation Llc10%

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

Brand names on the register (sample)

Zavation3P Hip System130 DEG EXT FEM NECK FIX PLATE, 6-HOLE130 DEG EXT FEM NECK FIX PLATE, 5-HOLE130 DEG EXT FEM NECK FIX PLATE, 4-HOLE130 DEG FEM NECK FIX PLATE 6-HOLE130 DEG FEM NECK FIX PLATE 5-HOLE130 DEG FEM NECK FIX PLATE 4-HOLE

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

FDA product codes

CodeNameDevices
HRSPlate, fixation, bone484
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple 6
NKBThoracolumbosacral Pedicle Screw System1
KWQAppliance, Fixation, Spinal Intervertebral Body1

GMDN & GCC registration

  • GMDN code 66945 · implantable
  • Single‑use 100% · 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) · 6

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

How many femoral neck fixation plate/sleeve products are registered in the US?

491 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Femoral neck fixation plate/sleeve", from 3 companies. The largest labeler is Orthopediatrics Corp. with 99% of records.

Which FDA product codes apply?

HRS (Plate, fixation, bone), KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ), NKB (Thoracolumbosacral Pedicle Screw System), KWQ (Appliance, Fixation, Spinal Intervertebral Body)

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.

How do I get quotes?

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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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