FDA.reportPublic FDA data

TriLeap Lower Extremity Anatomic Plating System

Primary DI
00810112596014
Brand
TriLeap Lower Extremity Anatomic Plating System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
TN Ti Fusion plate, Short
Catalog number
04.900.051
Device description
TN Ti Fusion plate, Short
Published
2024-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
00810112596014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112596014008101125960148101125960140810112596014

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; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058864308
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592924TriLeap Lower Extremity Anatomic Plating System2.0 mm Ti Cortex Screw Length 13 mm, Blue04.901.0132024-02-21
00810112595758TriLeap Lower Extremity Anatomic Plating System1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, L04.900.0192024-02-16
00810112592443TriLeap Lower Extremity Anatomic Plating SystemLapidus Screw Targeting Guide Left03.900.3982024-02-23
00810112596748TriLeap Lower Extremity Anatomic Plating System04.900.146049001462026-02-13
00810112596779TriLeap Lower Extremity Anatomic Plating System04.900.149049001492026-02-13
00810112598063MOTOBAND InstrumentsVIRTUGUIDE 0 RAC ROTATION - 10° - RT380004R-NSPKG2024-08-01
00810112598421MOTOBAND InstrumentsVIRTUGUIDE 1 RAC ROTATION - 5° - LT380006L-NSPKG2024-08-01
00815432022878MotoBANDMotoBAND CP, Non-Locking Screw, 3.5mm x 18mm - Ste1500-35182016-04-26
00810112593839TriLeap Lower Extremity Anatomic Plating System3.0 mm Ti Variable Angle Screw Length 9 mm, Gold04.906.0092024-02-22
00810112594669TriLeap Lower Extremity Anatomic Plating System3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple04.909.0322024-02-22
00810112595871TriLeap Lower Extremity Anatomic Plating System1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, 04.900.0332024-02-16
00815432026241HiMAX C7115-1515-C7115-1515-C2022-01-04
00815432029563MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threa15FT-35342021-12-17
00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
00815432025459MotoBANDMotoBAND CP, Non-Locking Screw, 3mm x 28mm - Steri15NL-30282018-07-02
00815432026258HiMAX C7115-1818-C7115-1818-C2022-01-04
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27
00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
00815432028832MotoBANDImplant, 3.5mm x 38mm Anti-Drift Bolt15LP-35382020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
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