Consulting Wallah › Device Explorer › Orthopaedic implants › Surgical implant template, single-use
Device Explorer · FDA GUDID · GMDN 58804

Surgical implant template, single-use

A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut met

US‑registered devices1,245in commercial distribution
Companies37labelers on GUDID
Single‑use91%of device records
Sterile13%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Restor3D, Inc.76862%
Kls-Martin L.P.21017%
Jeil Medical Corporation1069%
Stryker Leibinger Gmbh & Co. Kg423%
Newclip Technics282%
Nuvasive Specialized Orthopedics, Inc.121%
3D Systems, Inc.81%
Arthrex, Inc.60%

Top labelers

CompanyDevicesShare
Restor3D, Inc.76862%
Kls-Martin L.P.21017%
Jeil Medical Corporation1069%
Stryker Leibinger Gmbh & Co. Kg423%
Newclip Technics282%
Nuvasive Specialized Orthopedics, Inc.121%
3D Systems, Inc.81%
Arthrex, Inc.60%
Vb Spine Llc60%
Synthes Gmbh60%
Trimed, Inc.50%
Boston Medical Products, Inc.40%

Company = labeler of record on GUDID. 37 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NACarboClear Pedicle Screw SystemMontgomery® Thyroplasty Measuring KitK-RODNewclip InstrumentsSightLineMAVEN™ Patient-Specific InstrumentationAPEX 3D Total Ankle Replacement SystemArthrex®PURE PECTUSTEMPLATE, STERILELEVEL ONE CMF, STERILETEMPLATELEVEL ONE THORACIC, STERILERESORB X, STERILEDISTRACTION, INTERNAL, STERILE

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

FDA product codes

CodeNameDevices
SAIAnkle Fusion Cage768
HWTTEMPLATE293
HWTTemplate137
LXHOrthopedic Manual Surgical Instrument29
JEYPLATE, BONE27
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT15

GMDN & GCC registration

  • GMDN code 58804 · non‑implantable
  • Single‑use 91% · sterile 13% · Rx‑only 97% · 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) · 1

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

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

1,245 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical implant template, single-use", from 37 companies. The largest labeler is Restor3D, Inc. with 62% of records.

Which FDA product codes apply?

SAI (Ankle Fusion Cage), HWT (TEMPLATE), HWT (Template), 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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