FDA.reportPublic FDA data

Power Tool TL Attachment 2.5mm

Primary DI
07640187462302
Brand
Power Tool TL Attachment 2.5mm
Company
Bonebridge AG
Model
B-410014
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187462302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187462302076401874623027640187462302

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument torque limiterA small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480244832
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftB-2611002026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightB-2621002026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftB-2612002026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightB-2622002026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftB-2613002026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightB-2623002026-05-22
07640187463460POYA Medial TemplateB-4200452026-05-22
07640187462760TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, LeftB-1214002026-01-16
07640187462777TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, RightB-1224002026-01-16
07640187463125Lag Screw Drill Guide 2.5mmB-4100192026-01-16
07640187463132Drill Bit Ø2.5mm x 140mmB-4200442026-01-16
07640187463149Bending Iron SmallB-4100212026-01-16
07640187463156Bending Plier SmallB-4100222026-01-16
07640187463163Cutting PlierB-4100232026-01-16
07640187463101Monoaxial Drill Guide 2.5mmB-4100172026-01-15
07640187463118Insert Monoaxial Drill Guide 2.5mmB-4100182026-01-15
07640187463187BRUSIO 2.5mm Reinforced Straight Plate, 6 HoleB-1710062026-01-15
07640187463194BRUSIO 2.5mm Reinforced Straight Plate, 10 HoleB-1710102026-01-15
07640187463200BRUSIO 2.5mm Reinforced Straight Plate, 14 HoleB-1710142026-01-15
07640187463217BRUSIO 2.5mm Reinforced Straight Plate, 18 HoleB-1710182026-01-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-23
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
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00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
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10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
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