FDA.reportPublic FDA data

Taurus Pedicle Screw System

Primary DI
M555513065035
Brand
Taurus Pedicle Screw System
Company
SINTX Technologies, Inc.
Model
B
Catalog number
51-3065-035
Device description
Taurus Pedicle Screw System- Screw, Pedicle TL 6.5x35mm
Published
2017-12-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M555513065035PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Outer Diameter6.5Millimeter

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
G817103151100SiNAPTIC Osteotomy Wedge SystemInserter - Rev. 0103-15-11002026-04-06
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
00199150015832INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016044INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016051INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016068INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016075INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016082INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
00199150016099INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13