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Device Explorer · FDA GUDID · GMDN 34017

Sternal fixation device

A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of t

US‑registered devices696in commercial distribution
Companies16labelers on GUDID
Single‑use97%of device records
Sterile51%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Jeil Medical Corporation20830%
Biomet Microfixation, Inc9614%
J.M. Longyear Manufacturing, Llc659%
Stryker Leibinger Gmbh & Co. Kg619%
Synthes Gmbh558%
Kls-Martin L.P.527%
Medicon Eg. Chirurgiemechaniker-Genossenschaft375%
Fusion Innovations Llc284%

Top labelers

CompanyDevicesShare
Jeil Medical Corporation20830%
Biomet Microfixation, Inc9614%
J.M. Longyear Manufacturing, Llc659%
Stryker Leibinger Gmbh & Co. Kg619%
Synthes Gmbh558%
Kls-Martin L.P.527%
Medicon Eg. Chirurgiemechaniker-Genossenschaft375%
Fusion Innovations Llc284%
Gm Dos Reis Industria E Comercio Ltda243%
A & E Medical Corporation223%
Circumfix Solutions, Inc.152%
Medxpert Gmbh132%

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

Brand names on the register (sample)

NAAXS, SmartLockTitanium Sternum Triple-clip M/M/LTitanium Sternum Triple-clip S/S/MTitanium Sternum Triple-clip LTitanium Sternum Triple-clip MTitanium Sternum Triple-clip STitanium Sternum Double-clip M/LTitanium Sternum Double-clip S/MTitanium Sternum Double-clip LTitanium Sternum Double-clip MTitanium Sternum Double-clip STitanium Sternum Single-clip LTitanium Sternum Single-clip MTitanium Sternum Single-clip SMedicon

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, bone356
HWCScrew, Fixation, Bone253
HWCScrew, fixation, bone175
JDQCERCLAGE, FIXATION148
HRSPLATE, FIXATION, BONE144
HRSPlate, Fixation, Bone113

GMDN & GCC registration

  • GMDN code 34017 · implantable
  • Single‑use 97% · sterile 51% · Rx‑only 94% · 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) · 52Outer Diameter (Millimeter) · 12Length (Centimeter) · 1Length (Inch) · 1

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

How many sternal fixation device products are registered in the US?

696 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sternal fixation device", from 16 companies. The largest labeler is Jeil Medical Corporation with 30% of records.

Which FDA product codes apply?

HRS (Plate, fixation, bone), HWC (Screw, Fixation, Bone), HWC (Screw, fixation, bone), JDQ (CERCLAGE, 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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