FDA.reportPublic FDA data

TriLeap Lower Extremity Anatomic Plating System

Primary DI
00810112593136
Brand
TriLeap Lower Extremity Anatomic Plating System
Company
Synthes GmbH
Model
04.902.020
Catalog number
04902020
Device description
TriLEAP(TM) 2.0 mm Ti Variable Angle Screw Length 20 mm, Blue
Published
2024-02-22
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230591000
K253178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230591000TriLEAP Plating SystemCrossroads Extremity Systems2023-09-29HRS
K253178000TRILEAP Plating SystemCrossroads Extremity Systems2026-01-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112593136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112593136008101125931368101125931360810112593136

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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 GmbHHWC2024-02-23
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22