ACIS 08843309S

GUDID H98108843309S0

ACIS IMPLANT-STERILE LORDOTIC/LARGE-9MM HEIGHT

Synthes GmbH

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: H98108843309S0
• NIH Device Record Key: aded4955-170d-44fd-9dfc-33349245492f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIS
• Version Model Number: 08.843.309S
• Catalog Number: 08843309S
• 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	10705034762142 [Primary]
HIBCC	H98108843309S0 [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

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

Moist Heat or Steam Sterilization

[H98108843309S0]

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