Consulting Wallah › Device Explorer › Other devices › Surgical countersink, single-use
Device Explorer · FDA GUDID · GMDN 47634

Surgical countersink, single-use

A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The

US‑registered devices200in commercial distribution
Companies21labelers on GUDID
Single‑use83%of device records
Sterile33%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Fusion Orthopedics, Llc4221%
Tyber Medical, Llc3718%
Newclip Technics178%
Orthofix Srl168%
Ortho Solutions Holdings Limited147%
Stryker Gmbh116%
Gramercy Extremity Orthopedics Llc94%
Cg Medtech Co.,Ltd.94%

Top labelers

CompanyDevicesShare
Fusion Orthopedics, Llc4221%
Tyber Medical, Llc3718%
Newclip Technics178%
Orthofix Srl168%
Ortho Solutions Holdings Limited147%
Stryker Gmbh116%
Gramercy Extremity Orthopedics Llc94%
Cg Medtech Co.,Ltd.94%
Biomet Orthopedics, Llc63%
Osteomed Llc63%
Stryker Leibinger Gmbh & Co. Kg52%
Wright Medical Technology, Inc.42%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAORTHO SOLUTIONS SUCCESSION AFN SYSTEMCOGNiTiON™ Staple SystemVolition Plating SystemVolition™ Plating SystemORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR PROFYLEAsnisDELTANewclip InstrumentsDART-FIREMICAPhantom® Fibula Nail SystemPrecision MIS Bunion SystemArthrex®

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, Bone38
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT32
HTOReamer28
HWWCOUNTERSINK24
HTWBIT, DRILL17
HWWCountersink11

GMDN & GCC registration

  • GMDN code 47634 · non‑implantable
  • Single‑use 83% · sterile 33% · Rx‑only 86% · 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) · 18Outer Diameter (Millimeter) · 10Length (Inch) · 2

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

How many surgical countersink, single-use products are registered in the US?

200 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical countersink, single-use", from 21 companies. The largest labeler is Fusion Orthopedics, Llc with 21% of records.

Which FDA product codes apply?

HWC (Screw, Fixation, Bone), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HTO (Reamer), HWW (COUNTERSINK)

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.

How do I get quotes?

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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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