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Device Explorer · FDA GUDID · GMDN 61670

Implantable bone washer

An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

US‑registered devices683in commercial distribution
Companies65labelers on GUDID
Single‑use97%of device records
Sterile17%labelled sterile
Prescription95%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Stryker Gmbh639%
Synthes Gmbh436%
Medartis Ag436%
Smith & Nephew, Inc.406%
Extremity Medical, Llc396%
Depuy Spine, Llc386%
Tyber Medical, Llc355%
Neoortho Produtos Ortopédicos S/A.325%

Top labelers

CompanyDevicesShare
Stryker Gmbh639%
Synthes Gmbh436%
Medartis Ag436%
Smith & Nephew, Inc.406%
Extremity Medical, Llc396%
Depuy Spine, Llc386%
Tyber Medical, Llc355%
Neoortho Produtos Ortopédicos S/A.325%
Arthrex, Inc.315%
Biomet Orthopedics, Llc233%
Paragon 28, Inc.193%
Vilex Llc172%

Company = labeler of record on GUDID. 65 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2ASNISVARIAXNAHOFFMANNPROPROFYLEAsnisGAP ENDO-EXO MEDULLARY SYSTEMVolition Plating SystemVolition™ Plating SystemOrthoSolutions 'System26' Bone ScrewsMicroware Bone Plates and Bone ScrewsVariAxSPSMECRON™ Washer

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

FDA product codes

CodeNameDevices
HWCScrew, fixation, bone182
HTNWASHER, BOLT NUT133
HTNWasher, Bolt Nut126
MNHOrthosis, spondylolisthesis spinal fixation93
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL93
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY80

GMDN & GCC registration

  • GMDN code 61670 · implantable
  • Single‑use 97% · sterile 17% · Rx‑only 95% · 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

Outer Diameter (Millimeter) · 50Width (Millimeter) · 6Lumen/Inner Diameter (Millimeter) · 5Length (Millimeter) · 5Circumference (Millimeter) · 2Height (Inch) · 1

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

How many implantable bone washer products are registered in the US?

683 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Implantable bone washer", from 65 companies. The largest labeler is Stryker Gmbh with 9% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), HTN (WASHER, BOLT NUT), HTN (Washer, Bolt Nut), MNH (Orthosis, spondylolisthesis spinal fixation)

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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