FDA.reportPublic FDA data

TriLEAP

Primary DI
00810112597462
Brand
TriLEAP
Company
Synthes GmbH
Model
03.900.372
Catalog number
03900372
Device description
TriLEAP(TM) 3.0/4.5 mm Double Drill Guide for Jones Screws 4.5 mm
Published
2026-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112597462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112597462008101125974628101125974620810112597462

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
480426451
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19
00810112597226TriLEAP04.913.045049130452026-02-19
00810112597233TriLEAP04.913.050049130502026-02-19
00810112597240TriLEAP04.913.055049130552026-02-19
00810112597257TriLEAP04.913.060049130602026-02-19
00810112597264TriLEAP04.913.065049130652026-02-19
00810112597271TriLEAP04.914.035049140352026-02-19
00810112597288TriLEAP04.914.040049140402026-02-19
00810112597295TriLEAP04.914.050049140502026-02-19
00810112597301TriLEAP04.914.045049140452026-02-19
00810112597318TriLEAP04.914.055049140552026-02-19
00810112597325TriLEAP04.914.060049140602026-02-19
00810112597332TriLEAP04.914.065049140652026-02-19
00810112598933TriLEAP04.900.118049001182026-02-19
00810112598940TriLEAP04.900.119049001192026-02-19
00810112598957TriLEAP04.900.120049001202026-02-19
00810112598964TriLEAP04.900.121049001212026-02-19
00810112598971TriLEAP04.900.122049001222026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121916Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121923Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121930Working Tube with Handle, long lipJoimax GmbHFZX2026-10-22
04250337122029Guiding Rod, conicalJoimax GmbHFZX2026-10-22
04250337122036Guiding Rod, conical, greenJoimax GmbHFZX2026-10-22
00810055071210OviTex®TELA BIO, INC.FZX2026-10-21
00190446960362DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
00190446960379DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
10840143919350AtriClip® Selection GuideATRICURE, INC.FZX2026-10-09
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810112597479TriLEAPSynthes GmbHFZX2026-02-10
00810112598926TriLEAPSynthes GmbHFZX2026-02-10
00810056993139corraCarlsmed, Inc.FZX2026-01-30
00810112592405TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHFZX2024-02-23