ACIS 08843409S

GUDID H98108843409S0

ACIS IMPLANT-STERILE PARALLEL/LARGE-9MM HEIGHT

Synthes GmbH

Polymeric spinal interbody fusion cage

• Primary Device ID: H98108843409S0
• NIH Device Record Key: 197e5ff2-4c84-4d16-b1cc-f91cde58855a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIS
• Version Model Number: 08.843.409S
• Catalog Number: 08843409S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034762302 [Primary]
HIBCC	H98108843409S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120275

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

[H98108843409S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-27
• Device Publish Date: 2015-09-14

On-Brand Devices [ACIS]

• 07611819543072: ACIS ENDPLATE RASP
• 07611819473102: REPLACEMENT KNOB FOR ACIS IMPLANT INSERTER
• H981SD038410110: ACIS STANDARD LORDOTIC TRIAL WITH STOP 11MM-12MM
• H981SD038410090: ACIS STANDARD LORDOTIC TRIAL WITH STOP 9MM-10MM
• H981SD038410070: ACIS STANDARD LORDOTIC TRIAL WITH STOP 7MM-8MM
• H981SD038410050: ACIS STANDARD LORDOTIC TRIAL WITH STOP 5MM-6MM
• H98108843409S0: ACIS IMPLANT-STERILE PARALLEL/LARGE-9MM HEIGHT
• H98108843310S0: ACIS IMPLANT-STERILE LORDOTIC/LARGE-10MM HEIGHT
• H98108843309S0: ACIS IMPLANT-STERILE LORDOTIC/LARGE-9MM HEIGHT
• H98108843308S0: ACIS IMPLANT-STERILE LORDOTIC/LARGE-8MM HEIGHT
• H98108843305S0: ACIS IMPLANT-STERILE LORDOTIC/LARGE-5MM HEIGHT
• H98108843211S0: ACIS IMPLANT-STERILE CONVEX/STANDARD-11MM HEIGHT
• H98108843112S0: ACIS IMPLANT-STERILE PARALLEL/STANDARD-12MM HEIGHT
• H98108843108S0: ACIS IMPLANT-STERILE PARALLEL/STANDARD-8MM HEIGHT
• H98108843105S0: ACIS IMPLANT-STERILE PARALLEL/STANDARD-5MM HEIGHT
• H98108843005S0: ACIS IMPLANT-STERILE LORDOTIC/STANDARD-5MM HEIGHT