FDA.reportPublic FDA data

Syntec OS Spinal Fixation System

Primary DI
04719873284986
Brand
Syntec OS Spinal Fixation System
Company
SYNTEC SCIENTIFIC CORPORATION
Model
823745
Catalog number
823745
Device description
Polyaxial Pedicle Screwφ6.5 x L45mm
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873284986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873284986047198732849864719873284986

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657692971
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716873713751Syntec OS Spinal Fixation System8860088860082026-02-05
04719864661383Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020082020082026-02-05
04719864661390Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020102020102026-02-05
04719864661406Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020122020122026-02-05
04719864661413Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2020142020142026-02-05
04719864661574Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040142040142026-02-05
04719864661581Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040162040162026-02-05
04719864661598Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2040182040182026-02-05
04719864662830Syntec Osteo-plate and screw Fixation 2060142060142026-02-05
04719864662847Syntec Osteo-plate and screw Fixation 2060162060162026-02-05
04719864662854Syntec Osteo-plate and screw Fixation 2060182060182026-02-05
04719864679852Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2431602431602026-02-05
04719864679876Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413502413502026-02-05
04719864683736Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480502480502026-02-05
04719864683743Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480602480602026-02-05
04719864683750Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2480702480702026-02-05
04719864683996Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413602413602026-02-05
04719864684009Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2413702413702026-02-05
04719864684078Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420502420502026-02-05
04719864684085Syntec-Taichung Non-sterile Bone Plate and Screw Implants 2420602420602026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
03701313009632KHEIRONS.M.A.I.ONKB2026-10-23
03701313009649KHEIRONS.M.A.I.ONKB2026-10-23
03701313009656KHEIRONS.M.A.I.ONKB2026-10-23
03701313009663KHEIRONS.M.A.I.ONKB2026-10-23
03701313009670KHEIRONS.M.A.I.ONKB2026-10-23
03701313009687KHEIRONS.M.A.I.ONKB2026-10-23
03701313009694KHEIRONS.M.A.I.ONKB2026-10-23
03701313009700KHEIRONS.M.A.I.ONKB2026-10-23
03701313009717KHEIRONS.M.A.I.ONKB2026-10-23
03701313009724KHEIRONS.M.A.I.ONKB2026-10-23
03701313009731KHEIRONS.M.A.I.ONKB2026-10-23
03701313009748KHEIRONS.M.A.I.ONKB2026-10-23
03701313009755KHEIRONS.M.A.I.ONKB2026-10-23
03701313009762KHEIRONS.M.A.I.ONKB2026-10-23
03701313009779KHEIRONS.M.A.I.ONKB2026-10-23
03701313009786KHEIRONS.M.A.I.ONKB2026-10-23
03701313009793KHEIRONS.M.A.I.ONKB2026-10-23
03701313009809KHEIRONS.M.A.I.ONKB2026-10-23
03701313010027KHEIRONS.M.A.I.ONKB2026-10-23
03701313010034KHEIRONS.M.A.I.ONKB2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22