FDA.reportPublic FDA data

TriLEAP

Primary DI
00810112596335
Brand
TriLEAP
Company
Synthes GmbH
Model
04.900.085
Catalog number
04900085
Device description
TriLEAP(TM) 3.0/3.5/4.0 L-Shape Ti Plate, 4 Hole, Right
Published
2026-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253178000TRILEAP Plating SystemCrossroads Extremity Systems2026-01-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112596335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112596335008101125963358101125963350810112596335

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
false
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
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593075TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593082TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593105TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593112TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593136TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593150TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593167TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593174TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593181TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22