Axon 04200614

GUDID H981042006140

3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH

SYNTHES (U.S.A.) LP

Spinal bone screw, non-bioabsorbable

• Primary Device ID: H981042006140
• NIH Device Record Key: 27ba851b-df20-4f0f-a02a-19bc2cb05d20
• Commercial Distribution Discontinuation: 2020-09-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Axon
• Version Model Number: 04.200.614
• Catalog Number: 04200614
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034733586 [Primary]
HIBCC	H981042006140 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023675

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

[H981042006140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-12
• Device Publish Date: 2015-09-14

On-Brand Devices [Axon]

• H981690053700: GRAPHIC CASE MODULE F/AXON(TM) LCKNG SCR/RODS/HOOKS/CONNECTO
• H9816900534000: SCREW RACK FOR 3.5MM TI CORTEX AXON(TM) SCREWS
• H981690053400: IMPLANT TRAY FOR AXON(TM) GRAPHIC CASE
• H9816900533000: SCREW RACK FOR 3.5MM & 4.0MM TI CANCELLOUS AXON(TM) SCREWS
• H981690053300: TOP INSTRUMENT TRAY FOR AXON(TM) GRAPHIC CASE
• H981690053110: LID FOR AXON(TM) GRAPHIC CASE
• H981690053100: GRAPHIC CASE BASE WITHOUT LID FOR AXON(TM) GRAPHIC CASE
• H9816901680: GRAPHIC CASE FOR AXON(TM) AUXILIARY SCREWS
• H9816901670: AXON(TM) AUXILIARY SCREW RACK
• 07611819772373: PERSUADER FOR AXON(TM)
• 10705034793955: LONG TI AXON(TM) HOOK LEFT
• 10705034793948: LONG TI AXON(TM) HOOK RIGHT
• 10705034793931: SHORT TI AXON(TM) HOOK LEFT
• 10705034793924: SHORT TI AXON(TM) HOOK RIGHT
• H9814055260: 3.5MM TI CANCELLOUS AXON(TM) SCREW 26MM THREAD LENGTH
• H9814055240: 3.5MM TI CANCELLOUS AXON(TM) SCREW 24MM THREAD LENGTH
• H9814055220: 3.5MM TI CANCELLOUS AXON(TM) SCREW 22MM THREAD LENGTH
• H9814055200: 3.5MM TI CANCELLOUS AXON(TM) SCREW 20MM THREAD LENGTH
• H9814055180: 3.5MM TI CANCELLOUS AXON(TM) SCREW 18MM THREAD LENGTH
• H9814055160: 3.5MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH
• H9814055140: 3.5MM TI CANCELLOUS AXON(TM) SCREW 14MM THREAD LENGTH
• H9814055120: 3.5MM TI CANCELLOUS AXON(TM) SCREW 12MM THREAD LENGTH
• H9814055100: 3.5MM TI CANCELLOUS AXON(TM) SCREW 10MM THREAD LENGTH
• H9814055080: 3.5MM TI CANCELLOUS AXON(TM) SCREW 8MM THREAD LENGTH
• H9814054930: 3.5MM TI AXON(TM) SHAFT SCREW 36MM
• H9814054920: 3.5MM TI AXON(TM) SHAFT SCREW 34MM
• H9814054910: 3.5MM TI AXON(TM) SHAFT SCREW 32MM
• H9814054900: 3.5MM TI AXON(TM) SHAFT SCREW 30MM
• H9814054890: 3.5MM TI AXON(TM) SHAFT SCREW 28MM
• H9814054880: 3.5MM TI AXON(TM) SHAFT SCREW 26MM
• H9814054870: 3.5MM TI AXON(TM) SHAFT SCREW 24MM
• H9814054860: 3.5MM TI AXON(TM) SHAFT SCREW 22MM
• H9814054760: 4.0MM TI CANCELLOUS AXON(TM) SCREW 26MM THREAD LENGTH
• H9814054740: 4.0MM TI CANCELLOUS AXON(TM) SCREW 24MM THREAD LENGTH
• H9814054720: 4.0MM TI CANCELLOUS AXON(TM) SCREW 22MM THREAD LENGTH
• H9814054700: 4.0MM TI CANCELLOUS AXON(TM) SCREW 20MM THREAD LENGTH
• H9814054680: 4.0MM TI CANCELLOUS AXON(TM) SCREW 18MM THREAD LENGTH
• H9814054660: 4.0MM TI CANCELLOUS AXON(TM) SCREW 16MM THREAD LENGTH
• H9814054640: 4.0MM TI CANCELLOUS AXON(TM) SCREW 14MM THREAD LENGTH
• H9814054620: 4.0MM TI CANCELLOUS AXON(TM) SCREW 12MM THREAD LENGTH
• H9814054600: 4.0MM TI CANCELLOUS AXON(TM) SCREW 10MM THREAD LENGTH
• H9814054580: 4.0MM TI CANCELLOUS AXON(TM) SCREW 8MM THREAD LENGTH
• H9814045500: 3.5MM TI CORTEX AXON(TM) SCREW 50MM THREAD LENGTH
• H9814045480: 3.5MM TI CORTEX AXON(TM) SCREW 48MM THREAD LENGTH
• H9814045460: 3.5MM TI CORTEX AXON(TM) SCREW 46MM THREAD LENGTH
• H9814045440: 3.5MM TI CORTEX AXON(TM) SCREW 44MM THREAD LENGTH
• H9814045420: 3.5MM TI CORTEX AXON(TM) SCREW 42MM THREAD LENGTH
• H9814045400: 3.5MM TI CORTEX AXON(TM) SCREW 40MM THREAD LENGTH
• H9814045380: 3.5MM TI CORTEX AXON(TM) SCREW 38MM THREAD LENGTH
• H9814045360: 3.5MM TI CORTEX AXON(TM) SCREW 36MM THREAD LENGTH