FDA.reportPublic FDA data

Axon

Primary DI
10705034779157
Brand
Axon
Company
SYNTHES (U.S.A.) LP
Model
405.486
Catalog number
405486
Device description
3.5MM TI AXON(TM) SHAFT SCREW 22MM
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023675000SYNTHES CERVIFIX/ AXONSynthes (Usa)2002-11-26KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034779157PrimaryGS10
H9814054860SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477915710705034779157

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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
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10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
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00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-09-17
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00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2015-08-05
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04546540147769XIA IIStryker CorporationKWP2014-12-08
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04546540147905XIA IIStryker CorporationKWP2014-12-08
04546540147912XIA IStryker CorporationKWP2014-12-08
04546540147929XIA IStryker CorporationKWP2014-12-08
04546540147936XIA IStryker CorporationKWP2014-12-08
04546540147974XIA IStryker CorporationKWP2014-12-08
04546540147981XIA IStryker CorporationKWP2014-12-08
04546540147998XIA IStryker CorporationKWP2014-12-08
04546540148001XIA IIStryker CorporationKWP2014-12-08
04546540148018XIA IIStryker CorporationKWP2014-12-08
04546540148025XIA IIStryker CorporationKWP2014-12-08