FDA.reportPublic FDA data

Axon

Primary DI
10705034779003
Brand
Axon
Company
SYNTHES (U.S.A.) LP
Model
404.542
Catalog number
404542
Device description
3.5MM TI CORTEX AXON(TM) SCREW 42MM THREAD LENGTH
Published
2015-09-14
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
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034779003PrimaryGS10
H9814045420SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477900310705034779003

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00763000992576INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992583INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992590INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992606INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992613INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992620INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992712INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992729INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992736INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992743INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992750INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992767INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992774INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992781INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992798INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992804INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992897INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992903INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992910INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992927INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992934INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992941INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992958INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992965INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992972INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000992989INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
00763000993078INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17