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Device Explorer · FDA GUDID · GMDN 56642

Orthopaedic bone screw, non-bioabsorbable, non-sterile

"A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tiss

US‑registered devices27,843in commercial distribution
Companies72labelers on GUDID
Single‑use99%of device records
Sterile2%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc2,81610%
Medartis Ag2,1348%
Jeil Medical Corporation1,8117%
Wright Medical Technology, Inc.1,4375%
Paragon 28, Inc.1,3845%
Neoortho Produtos Ortopédicos S/A.1,3145%
Smith & Nephew, Inc.1,1234%
Osteomed Llc1,0864%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc2,81610%
Medartis Ag2,1348%
Jeil Medical Corporation1,8117%
Wright Medical Technology, Inc.1,4375%
Paragon 28, Inc.1,3845%
Neoortho Produtos Ortopédicos S/A.1,3145%
Smith & Nephew, Inc.1,1234%
Osteomed Llc1,0864%
Extremity Medical, Llc9834%
Vilex Llc9804%
Aap Implantate Ag9553%
Medical Facets Nc Llc9143%

Company = labeler of record on GUDID. 72 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PROMOSTI Snap-off Screw,self-drilling+ tapping,17mmTI Snap-off Screw,self-drilling+ tapping,16mmTI Snap-off Screw,self-drilling+ tapping,15mmTI Snap-off Screw,self-drilling+ tapping,14mmTI Snap-off Screw,self-drilling+ tapping,13mmTI Snap-off Screw,self-drilling+ tapping,12mmTI Snap-off Screw,self-drilling+ tapping,11mmTI Snap-off Screw,self-drilling+ tapping,10mmTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cannTI HBS self-drilling high compression screw,cann

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, bone14,293
HWCScrew, Fixation, Bone12,081
HRSPLATE, FIXATION, BONE3,823
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2,065
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 1,834
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 1,722

GMDN & GCC registration

  • GMDN code 56642 · non‑implantable
  • Single‑use 99% · sterile 2% · Rx‑only 90% · 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) · 5,463Outer Diameter (Millimeter) · 4,907Width (Millimeter) · 39Length (Micrometer) · 16Outer Diameter (Micrometer) · 5Circumference (Millimeter) · 1

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

How many orthopaedic bone screw, non-bioabsorbable, non-sterile products are registered in the US?

27,843 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone screw, non-bioabsorbable, non-sterile", from 72 companies. The largest labeler is Biomet Orthopedics, Llc with 10% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), HWC (Screw, Fixation, Bone), HRS (PLATE, FIXATION, BONE), HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES)

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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