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Device Explorer · FDA GUDID · GMDN 47863

Surgical instrument/implant depth limiter, reusable

A device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to

US‑registered devices705in commercial distribution
Companies49labelers on GUDID
Single‑use13%of device records
Sterile9%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Nuvasive, Inc.16924%
Osseus Fusion Systems, Llc9213%
Flower Orthopedics Corporation598%
W.H. Holden, Inc.527%
Etablissements Anthogyr426%
Depuy (Ireland)385%
Cg Medtech Co.,Ltd.325%
Smith & Nephew, Inc.254%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.16924%
Osseus Fusion Systems, Llc9213%
Flower Orthopedics Corporation598%
W.H. Holden, Inc.527%
Etablissements Anthogyr426%
Depuy (Ireland)385%
Cg Medtech Co.,Ltd.325%
Smith & Nephew, Inc.254%
Oco Biomedical Inc233%
Leith Medical Llc152%
Ossvis Co., Ltd.152%
United Orthopedic Corp.101%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GAP ENDO-EXO MEDULLARY SYSTEMCarboClear X Pedicle Screw SystemPiccolo Composite Nailing SystemDrill StopperAxis Spine Technologies ALIFAxis Spine Technologies ALIF System InstrumentU2 Total Knee SystemU2™ KneeUKNEE™Drill Depth Stop Cranial 4.9 mmDRILL DEPTH STOP CRANIAL 3.8Drill Depth Stop Cranial 2.5Drill Depth Stop Cranial 4.0N/ARetroTechAXIOM®

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 INSTRUMENT191
FZXGuide, Surgical, Instrument96
NDPAccessories, implant, dental, endosseous89
HWTTemplate56
HTJGAUGE, DEPTH55
NDPAccessories, Implant, Dental, Endosseous36

GMDN & GCC registration

  • GMDN code 47863 · non‑implantable
  • Single‑use 13% · sterile 9% · Rx‑only 82% · OTC 1%
  • 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) · 48Outer Diameter (Millimeter) · 47Length (Inch) · 15Height (Millimeter) · 4

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

How many surgical instrument/implant depth limiter, reusable products are registered in the US?

705 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument/implant depth limiter, reusable", from 49 companies. The largest labeler is Nuvasive, Inc. with 24% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, Surgical, Instrument), NDP (Accessories, implant, dental, endosseous), HWT (Template)

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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