FDA.report

T-25 Standard Driver

Primary DI
B064XM11504251
Brand
T-25 Standard Driver
Company
XENCO MEDICAL LLC
Model
XM-115-0425
Published
2016-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B064XM11504251PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
858-202-1505sarahdo@xencomedical.com

Regulatory Flags

DUNS number
079282130
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
B064XM3D31223121CancelleX™ 13mm x 12mm x 12mm x 12* Cervical InterbodyXM-3D-312-23122026-02-06
B064XM3D31225061CancelleX™ 15mm x 13mm x 6mm x 12* Cervical InterbodyXM-3D-312-25062026-02-06
B064XM3D31225071CancelleX™ 15mm x 13mm x 7mm x 12* Cervical InterbodyXM-3D-312-25072026-02-06
B064XM3D31225081CancelleX™ 15mm x 13mm x 8mm x 12* Cervical InterbodyXM-3D-312-25082026-02-06
B064XMPHCP6100818mm One Level Cervical PlateXM-PH-CP6-10082026-02-06
B064HB11200101Tube GuardHB-112-00102023-08-07
B064MPE010101Saratoga Cervical BraceMPE010102023-08-07
B064MPE010401Tahiti Lumbar BraceMPE010402023-08-07
B064XM11510001Pedicle Screw Instruments KitXM-115-10002022-08-11
B064XM1232345123mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm HeightsXM-123-23452015-10-28
B064XM1272345127mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm HeightsXM-127-23452015-10-28
B064XM1278901127mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm HeightsXM-127-89012015-10-28
B064XM1282345128mm x 11mm Oblique Trials 12, 13, 14, 15 mm HeightsXM-128-23452016-07-06
B064XM1288901128mm x 11mm Oblique Trial Kit 8, 9, 10, 11 mm HeightsXM-128-89012015-10-28
B064XM21565501Ø6.5mm x 50mm Pedicle Screw with Set Screw PackageXM-215-65502015-10-27
B064XM21565551Ø6.5mm x 55mm Pedicle Screw with Set Screw PackageXM-215-65552015-10-27
B064XM21575251Ø7.5mm x 25mm Pedicle Screw with Set Screw PackageXM-215-75252015-10-27
B064XM21575271Ø7.5mm x 27mm Pedicle Screw with Set Screw PackageXM-215-75272015-11-03
B064XM21575301Ø7.5mm x 30mm Pedicle Screw with Set Screw PackageXM-215-75302015-11-03
B064XM21575321Ø7.5mm x 32mm Pedicle Screw with Set Screw PackageXM-215-75322015-11-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810071391460Able Medical DevicesJ.M. Longyear Manufacturing, LLCHXX2026-05-26
00199150076185Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-05-23
00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00810076338545Momentum MIS - Modified InstrumentUlrich Medical Usa, Inc.HXX2026-03-02
00199150066902Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-02-28
03662663128780PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXX2026-02-11
03662663129084Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXX2026-02-11
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
00810112599756TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
10886982351586NASynthes GmbHHXX2026-02-10
10886982351593NASynthes GmbHHXX2026-02-10
00840180545225General InstrumentsALPHATEC SPINE, INC.HXX2026-01-29
10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
00199150060115Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489856Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29