FDA.reportPublic FDA data

TriLeap Lower Extremity Anatomic Plating System

Primary DI
00810112596250
Brand
TriLeap Lower Extremity Anatomic Plating System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
Pin Distractor
Catalog number
03.900.394
Device description
Pin Distractor
Published
2024-02-23
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

Product Codes#

Code, Name table
CodeName
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112596250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112596250008101125962508101125962500810112596250

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. 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
00815432024322DynaForce MotoBAND Max7100-4H157100-4H152022-12-09
00815432024339DynaForce MotoBAND Max7100-4H187100-4H182022-12-09
00815432024353DynaForce MotoBAND Max7100-5H187100-5H182022-12-09
00815432024360DynaForce MotoBAND Max7100-99PN7100-99PN2022-12-09
00815432024377DynaForce MotoBAND Max7100-RD157100-RD152022-12-09
00815432024391DynaForce MotoBAND Max7100-RP157100-RP152022-12-09
00815432024407DynaForce MotoBAND Max7100-RP187100-RP182022-12-09
00815432024421DynaForce MotoBAND Max7100-TJ187100-TJ182022-12-09
00815432024438DynaForce MotoBAND Max7100-ZA157100-ZA152022-12-09
00815432027989MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018R2020-11-12
00815432027996MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018R2020-11-12
00815432028009MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020R2020-11-12
00815432028016MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020R2020-11-12
00815432028023MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018L2020-11-12
00815432028030MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018L2020-11-12
00815432028047MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020L2020-11-12
00815432028054MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020L2020-11-12
00815432028726MotoBANDImplant, 3.5mm x 28mm Anti-Drift Bolt15LP-35282020-05-27
00815432028795MotoBANDImplant, 3.5mm x 30mm Anti-Drift Bolt15LP-35302020-05-27
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27

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Primary DI, Brand, Company table
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00810017915804SABER-XA, Height ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915811SABER-XA, Lordosis ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
08806373897344BENCOXCorentec Co., LtdHWB2026-07-01
08806373897351BENCOXCorentec Co., LtdHWB2026-07-01
08806373897368BENCOXCorentec Co., LtdHWB2026-07-01
08806373897375BENCOXCorentec Co., LtdHWB2026-07-01
08806373897382BENCOXCorentec Co., LtdHWB2026-07-01
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00810112598070MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHWB2024-07-31
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10