FDA.reportPublic FDA data

Acura Stabilization System

Primary DI
B922F005001505
Brand
Acura Stabilization System
Company
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Model
F005.0015
Catalog number
F005.0015
Device description
Long tab breaker (Nose Plier Type)
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B922F005001505PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1214-972-8683info@indiusmedical.com

Regulatory Flags#

DUNS number
860396609
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B922F004800208ACURA Stabilization SystemF004.8002F004.80022026-03-11
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
B922A00472600ACURA Stabilization System A004.7260A004.72602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03