Consulting Wallah › Device Explorer › Other devices › Orthopaedic bone washer, sterile
Device Explorer · FDA GUDID · GMDN 61671

Orthopaedic bone washer, sterile

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

US‑registered devices117in commercial distribution
Companies16labelers on GUDID
Single‑use99%of device records
Sterile97%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc2521%
Smith & Nephew, Inc.1412%
Osteomed Llc1210%
Gramercy Extremity Orthopedics Llc1210%
Newdeal119%
Ortho Solutions Holdings Limited109%
Orthofix Srl76%
Dunamis Medical, Llc54%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc2521%
Smith & Nephew, Inc.1412%
Osteomed Llc1210%
Gramercy Extremity Orthopedics Llc1210%
Newdeal119%
Ortho Solutions Holdings Limited109%
Orthofix Srl76%
Dunamis Medical, Llc54%
Medshape, Inc.43%
Citieffe Srl43%
Fastforward Surgical Inc33%
Innovision, Inc33%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR NATC-100Cannulated ScrewsLARGE CANNULATED SCREWSLG CANNULATED SCREWSFlat WasherCUP WASHERPLAIN WASHERA.L.P.S.®BIODRIVE SCREW SYSTEMFLAT WASHER8.0MMFLAT WASHER6.5MMFLAT WASHER5.0MMFLAT WASHER4.0MM

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, bone43
HRSPLATE, FIXATION, BONE28
HTNWASHER, BOLT NUT27
HTNWasher, Bolt Nut23
HWCScrew, Fixation, Bone16
HTYPIN, FIXATION, SMOOTH12

GMDN & GCC registration

  • GMDN code 61671 · non‑implantable
  • Single‑use 99% · sterile 97% · Rx‑only 91% · 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) · 11Lumen/Inner Diameter (Millimeter) · 3Outer Diameter (Inch) · 1

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

How many orthopaedic bone washer, sterile products are registered in the US?

117 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone washer, sterile", from 16 companies. The largest labeler is Biomet Orthopedics, Llc with 21% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), HRS (PLATE, FIXATION, BONE), HTN (WASHER, BOLT NUT), HTN (Washer, Bolt Nut)

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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