FDA.reportPublic FDA data

TriLeap Lower Extremity Anatomic Plating System

Primary DI
00810112598902
Brand
TriLeap Lower Extremity Anatomic Plating System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
03.900.402
Catalog number
03900402
Device description
TAMP FOR HOOK PLATES
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112598902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112598902008101125989028101125989020810112598902

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058864308
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
00810112596793TriLeap Lower Extremity Anatomic Plating System04.900.151049001512026-02-19
00810112597202TriLeap Lower Extremity Anatomic Plating System04.913.035049130352026-02-19
00810112597219TriLeap Lower Extremity Anatomic Plating System04.913.040049130402026-02-19
00810112597226TriLeap Lower Extremity Anatomic Plating System04.913.045049130452026-02-19
00810112597233TriLeap Lower Extremity Anatomic Plating System04.913.050049130502026-02-19
00810112597240TriLeap Lower Extremity Anatomic Plating System04.913.055049130552026-02-19
00810112597257TriLeap Lower Extremity Anatomic Plating System04.913.060049130602026-02-19
00810112597264TriLeap Lower Extremity Anatomic Plating System04.913.065049130652026-02-19
00810112597271TriLeap Lower Extremity Anatomic Plating System04.914.035049140352026-02-19
00810112597288TriLeap Lower Extremity Anatomic Plating System04.914.040049140402026-02-19
00810112597295TriLeap Lower Extremity Anatomic Plating System04.914.050049140502026-02-19
00810112597301TriLeap Lower Extremity Anatomic Plating System04.914.045049140452026-02-19
00810112597318TriLeap Lower Extremity Anatomic Plating System04.914.055049140552026-02-19
00810112597325TriLeap Lower Extremity Anatomic Plating System04.914.060049140602026-02-19
00810112597332TriLeap Lower Extremity Anatomic Plating System04.914.065049140652026-02-19
00810112598933TriLeap Lower Extremity Anatomic Plating System04.900.118049001182026-02-19
00810112598940TriLeap Lower Extremity Anatomic Plating System04.900.119049001192026-02-19
00810112598957TriLeap Lower Extremity Anatomic Plating System04.900.120049001202026-02-19
00810112598964TriLeap Lower Extremity Anatomic Plating System04.900.121049001212026-02-19
00810112598971TriLeap Lower Extremity Anatomic Plating System04.900.122049001222026-02-19

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Primary DI, Brand, Company table
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00190376700717IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00190776415723MillenniumAvalign Technologies, Inc.HXG2026-02-04
04026575341153Endo-Model Knee Fusion Nail SK InstrumentsWALDEMAR LINK GmbH & Co. KGHXG2026-02-02
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03662663254120Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
00190376662176IdentiTi IIALPHATEC SPINE, INC.HXG2025-12-08
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