Consulting Wallah › Device Explorer › Orthopaedic implants › Screw-extraction orthopaedic reamer, reusable
Device Explorer · FDA GUDID · GMDN 63980

Screw-extraction orthopaedic reamer, reusable

A surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting e

US‑registered devices89in commercial distribution
Companies11labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Gs Medical Co., Ltd.3034%
Orthopediatrics Corp.1517%
Gsource Llc1213%
Bradshaw Medical, Inc.1112%
Medfix International, Llc89%
Ortho-Design (Pty) Ltd44%
Life Spine, Inc.33%
Zavation Llc22%

Top labelers

CompanyDevicesShare
Gs Medical Co., Ltd.3034%
Orthopediatrics Corp.1517%
Gsource Llc1213%
Bradshaw Medical, Inc.1112%
Medfix International, Llc89%
Ortho-Design (Pty) Ltd44%
Life Spine, Inc.33%
Zavation Llc22%
Nexus Spine, L.L.C.22%
Pacific Instruments, Inc.11%
Orthofix Srl11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VersaTap Tip RecoveryVersaTap /VersaLat RecoveryVersaTap Tip RemovalVersaTap/Lat Removal ToolPacific InstrumentsZavationPediNail Intramedullary PlatformPediatric Nailing Platform TibiagSourcePediatric Nailing Platform FemurMedfixBradshaw Medical Inc.ZAVATION INSTRUMENTNautilusAVATAR Minimally Invasive Spinal SystemStable-L™

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument32
HTOREAMER15
HTOReamer13
HXXScrewdriver11
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT8
NBHAccessories, Arthroscopic4

GMDN & GCC registration

  • GMDN code 63980 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 78% · 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

Lumen/Inner Diameter (Millimeter) · 1

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

How many screw-extraction orthopaedic reamer, reusable products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Screw-extraction orthopaedic reamer, reusable", from 11 companies. The largest labeler is Gs Medical Co., Ltd. with 34% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), HTO (REAMER), HTO (Reamer), HXX (Screwdriver)

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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