FDA.reportPublic FDA data

Taurus Pedicle Screw System

Primary DI
M555503000011
Brand
Taurus Pedicle Screw System
Company
SINTX Technologies, Inc.
Model
X
Catalog number
50-3000-011
Device description
Driver, Polyaxial, 11in
Published
2018-04-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHXTrousers, Anti-Shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M555503000011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, single-useA 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-839-3500customerservice@amedica.com

Regulatory Flags#

DUNS number
028629553
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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G817103151200SiNAPTIC Osteotomy Wedge SystemTamp - Rev. 0103-15-12002026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216052026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216062026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216072026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216082026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216102026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1216122026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418052026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418062026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418072026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418082026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418102026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemCotton Trial - Rev. 0113-25-1418122026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemEvans Wedge - Rev. 1S-101-1818062026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216052026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216062026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216072026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216082026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemCotton Wedge - Rev. 0S-111-1216102026-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
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00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
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08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
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00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
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00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
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10889981308339SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308346SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308353SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308438SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16