FDA.report

ACURA Stabilization System - Torque Limiting Quick Connect T-handle (5.5 Nm)

Primary DI
B922IMDT00340
Brand
ACURA Stabilization System - Torque Limiting Quick Connect T-handle (5.5 Nm)
Company
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Model
IMDT.0034
Catalog number
IMDT.0034
Device description
Torque Limiting Quick Connect T-handle (5.5 Nm)
Published
2022-03-06
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B922IMDT00340PrimaryHIBCC0

GMDN Terms

TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1214-972-8683info@indiusmedical.com

Regulatory Flags

DUNS number
860396609
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
B922F004800208ACURA Stabilization SystemF004.8002F004.80022026-03-11
B922F005001505Acura Stabilization SystemF005.0015F005.00152026-03-11
B922F005001707ACURA Stabilization SystemF005.0017F005.00172026-03-11
B922F005001808ACURA Stabilization SystemF005.0018F005.00182026-03-11
B922F005003608ACURA Stabilization SystemF005.0036F005.00362026-03-11
B922F005003709ACURA Stabilization SystemF005.0037F005.00372026-03-11
B922F00500380ACURA Stabilization SystemF005.0038F005.00382026-03-11
B922F00500390ACURA Stabilization SystemF005.0039F005.00392026-03-11
B922IMDT00490ACURA Stabilization System IMDT.0049IMDT.00492026-03-11
B922F005000100Guidewire ( Non-Threaded)F005.0001F005.00012026-03-09
B922F005000201Access Needle (8 Gauge)F005.0002F005.00022026-03-09
B922F005000706Rod CaliperF005.0007F005.00072026-03-09
B922A00470200ACURA Stabilization SystemA004.7020A004.70202026-02-04
B922A00470250ACURA Stabilization SystemA004.7025A004.70252026-02-04
B922A00470300ACURA Stabilization SystemA004.7030A004.70302026-02-04
B922A00470350ACURA Stabilization SystemA004.7035A004.70352026-02-04
B922A00470400ACURA Stabilization SystemA004.7040A004.70402026-02-04
B922A00470450ACURA Stabilization SystemA004.7045A004.70452026-02-04
B922A00471250ACURA Stabilization SystemA004.7125A004.71252026-02-04
B922A0047130ACURA Stabilization SystemA004.7130A004.71302026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19