FDA.reportPublic FDA data

Axon

Primary DI
H9814045280
Brand
Axon
Company
SYNTHES (U.S.A.) LP
Model
404.528
Catalog number
404528
Device description
3.5MM TI CORTEX AXON(TM) SCREW 28MM 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
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034778938PrimaryGS10
H9814045280SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477893810705034778938

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
07290117359549CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
07290117359563CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDNKG2026-07-13
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-06-27
04052536163403neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGNKG2026-06-08
00840283403897VySpan™VY SPINE LLCNKG2026-06-05
00840283403927VySpan™VY SPINE LLCNKG2026-06-05
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
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