Consulting Wallah › Device Explorer › Orthopaedic implants › Orthopaedic bone screw (non-sliding)
Device Explorer · FDA GUDID · GMDN 66947

Orthopaedic bone screw (non-sliding)

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabi

US‑registered devices80,126in commercial distribution
Companies126labelers on GUDID
Single‑use99%of device records
Sterile30%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Synthes Gmbh8,19610%
Tyber Medical, Llc7,4879%
Zavation Llc5,2627%
Stryker Gmbh4,7836%
Arthrex, Inc.4,5886%
Smith & Nephew, Inc.4,3995%
Jeil Medical Corporation3,6105%
Zimmer, Inc.3,1774%

Top labelers

CompanyDevicesShare
Synthes Gmbh8,19610%
Tyber Medical, Llc7,4879%
Zavation Llc5,2627%
Stryker Gmbh4,7836%
Arthrex, Inc.4,5886%
Smith & Nephew, Inc.4,3995%
Jeil Medical Corporation3,6105%
Zimmer, Inc.3,1774%
Orthopediatrics Corp.2,4103%
Acumed Llc2,4093%
Microware Precision Co., Ltd.2,1743%
Trimed, Inc.1,7302%

Company = labeler of record on GUDID. 126 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2, PANGEAPANGEANAT2GAMMAASNISVARIAXAxSOS 3IMN ScrewsAXSOST2 ALPHAMINITrident IIANCHORAGEOMEGANUMELOCK II

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, bone42,389
HWCScrew, Fixation, Bone23,566
HRSPlate, fixation, bone7,464
HRSPLATE, FIXATION, BONE6,445
HRSPlate, Fixation, Bone4,755
NKBThoracolumbosacral Pedicle Screw System3,775

GMDN & GCC registration

  • GMDN code 66947 · implantable
  • Single‑use 99% · sterile 30% · Rx‑only 93% · 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) · 18,576Outer Diameter (Millimeter) · 7,826Width (Millimeter) · 52Lumen/Inner Diameter (Millimeter) · 39Height (Millimeter) · 16Angle (degree) · 13

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

How many orthopaedic bone screw (non-sliding) products are registered in the US?

80,126 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic bone screw (non-sliding)", from 126 companies. The largest labeler is Synthes Gmbh with 10% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), HWC (Screw, Fixation, Bone), HRS (Plate, fixation, bone), HRS (PLATE, FIXATION, BONE)

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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