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Device Explorer · FDA GUDID · GMDN 64237

Orthopaedic inorganic implant inserter/extractor, single-use

A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configur

US‑registered devices409in commercial distribution
Companies30labelers on GUDID
Single‑use94%of device records
Sterile32%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Shukla Medical24359%
Orthopediatrics Corp.246%
Alphatec Spine, Inc.205%
Arthrex, Inc.123%
Carlsmed, Inc.123%
Paragon 28, Inc.113%
Acuitive Technologies, Inc.92%
Carbofix Orthopedics Ltd82%

Top labelers

CompanyDevicesShare
Shukla Medical24359%
Orthopediatrics Corp.246%
Alphatec Spine, Inc.205%
Arthrex, Inc.123%
Carlsmed, Inc.123%
Paragon 28, Inc.113%
Acuitive Technologies, Inc.92%
Carbofix Orthopedics Ltd82%
Integrity Orthopaedics, Inc82%
Orthopediatrics Canada Ulc72%
Smith & Nephew, Inc.61%
Advanced Orthopaedic Solutions, Inc.61%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FASSIER-DUVAL TELESCOPIC IM SYSTEMCarboClear Posterior Cervical Screw SystemCarboClear Pedicle Screw SystemCarboClear Vertebral Body Replacement SystemAgili-C Mini Disposable ToolsetReActiv8 Release ToolREFLECTIONPhantom Hindfoot TTC/TC Nail SystemPhantom® Fibula Nail SystemIdentity® Shoulder SystemArthrex®Capture High Torque Screw SystemSurgical InstrumentsIntegrity OrthopaedicsEASY OUT EXTRACTOR, CLAVICLE IM DEVICEEASYOUT EXTRACTOR TIBIAL NAIL

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

FDA product codes

CodeNameDevices
HWBExtractor172
LXHOrthopedic Manual Surgical Instrument69
HWKTrephine42
LXHOrthopedic manual surgical instrument33
HXXSCREWDRIVER17
HWBEXTRACTOR16

GMDN & GCC registration

  • GMDN code 64237 · non‑implantable
  • Single‑use 94% · sterile 32% · Rx‑only 38% · 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) · 12

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

How many orthopaedic inorganic implant inserter/extractor, single-use products are registered in the US?

409 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic inorganic implant inserter/extractor, single-use", from 30 companies. The largest labeler is Shukla Medical with 59% of records.

Which FDA product codes apply?

HWB (Extractor), LXH (Orthopedic Manual Surgical Instrument), HWK (Trephine), LXH (Orthopedic manual surgical instrument)

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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