ACIS 08843205

GUDID H981088432050

ACIS IMPLANT CONVEX/STANDARD 5MM HEIGHT

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage

• Primary Device ID: H981088432050
• NIH Device Record Key: 187e3012-1b25-4bff-a2ca-3bb659f6ff47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIS
• Version Model Number: 08.843.205
• Catalog Number: 08843205
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034761893 [Primary]
HIBCC	H981088432050 [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: false

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

[H981088432050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-14

On-Brand Devices [ACIS]

• H981088438120: ACIS IMPLANT CONVEX/SMALL 12MM HEIGHT
• H981088438110: ACIS IMPLANT CONVEX/SMALL 11MM HEIGHT
• H981088438100: ACIS IMPLANT CONVEX/SMALL 10MM HEIGHT
• H981088438090: ACIS IMPLANT CONVEX/SMALL 9MM HEIGHT
• H981088438080: ACIS IMPLANT CONVEX/SMALL 8MM HEIGHT
• H981088438070: ACIS IMPLANT CONVEX/SMALL 7MM HEIGHT
• H981088438060: ACIS IMPLANT CONVEX/SMALL 6MM HEIGHT
• H981088438050: ACIS IMPLANT CONVEX/SMALL 5MM HEIGHT
• H981088437120: ACIS IMPLANT PARALLEL/SMALL 12MM HEIGHT
• H981088437110: ACIS IMPLANT PARALLEL/SMALL 11MM HEIGHT
• H981088437100: ACIS IMPLANT PARALLEL/SMALL 10MM HEIGHT
• H981088437090: ACIS IMPLANT PARALLEL/SMALL 9MM HEIGHT
• H981088437080: ACIS IMPLANT PARALLEL/SMALL 8MM HEIGHT
• H981088437070: ACIS IMPLANT PARALLEL/SMALL 7MM HEIGHT
• H981088437060: ACIS IMPLANT PARALLEL/SMALL 6MM HEIGHT
• H981088437050: ACIS IMPLANT PARALLEL/SMALL 5MM HEIGHT
• H981088436120: ACIS IMPLANT LORDOTIC/SMALL 12MM HEIGHT
• H981088436110: ACIS IMPLANT LORDOTIC/SMALL 11MM HEIGHT
• H981088436100: ACIS IMPLANT LORDOTIC/SMALL 10MM HEIGHT
• H981088436090: ACIS IMPLANT LORDOTIC/SMALL 9MM HEIGHT
• H981088436080: ACIS IMPLANT LORDOTIC/SMALL 8MM HEIGHT
• H981088436070: ACIS IMPLANT LORDOTIC/SMALL 7MM HEIGHT
• H981088436060: ACIS IMPLANT LORDOTIC/SMALL 6MM HEIGHT
• H981088436050: ACIS IMPLANT LORDOTIC/SMALL 5MM HEIGHT
• H981088434120: ACIS IMPLANT PARALLEL/LARGE 12MM HEIGHT
• H981088434110: ACIS IMPLANT PARALLEL/LARGE 11MM HEIGHT
• H981088434100: ACIS IMPLANT PARALLEL/LARGE 10MM HEIGHT
• H981088434090: ACIS IMPLANT PARALLEL/LARGE 9MM HEIGHT
• H981088434080: ACIS IMPLANT PARALLEL/LARGE 8MM HEIGHT
• H981088434070: ACIS IMPLANT PARALLEL/LARGE 7MM HEIGHT
• H981088434060: ACIS IMPLANT PARALLEL/LARGE 6MM HEIGHT
• H981088434050: ACIS IMPLANT PARALLEL/LARGE 5MM HEIGHT
• H981088433120: ACIS IMPLANT LORDOTIC/LARGE 12MM HEIGHT
• H981088433110: ACIS IMPLANT LORDOTIC/LARGE 11MM HEIGHT
• H981088433100: ACIS IMPLANT LORDOTIC/LARGE 10MM HEIGHT
• H981088433090: ACIS IMPLANT LORDOTIC/LARGE 9MM HEIGHT
• H981088433080: ACIS IMPLANT LORDOTIC/LARGE 8MM HEIGHT
• H981088433070: ACIS IMPLANT LORDOTIC/LARGE 7MM HEIGHT
• H981088433060: ACIS IMPLANT LORDOTIC/LARGE 6MM HEIGHT
• H981088433050: ACIS IMPLANT LORDOTIC/LARGE 5MM HEIGHT
• H981088432120: ACIS IMPLANT CONVEX/STANDARD 12MM HEIGHT
• H981088432110: ACIS IMPLANT CONVEX/STANDARD 11MM HEIGHT
• H981088432100: ACIS IMPLANT CONVEX/STANDARD 10MM HEIGHT
• H981088432090: ACIS IMPLANT CONVEX/STANDARD 9MM HEIGHT
• H981088432080: ACIS IMPLANT CONVEX/STANDARD 8MM HEIGHT
• H981088432070: ACIS IMPLANT CONVEX/STANDARD 7MM HEIGHT
• H981088432060: ACIS IMPLANT CONVEX/STANDARD 6MM HEIGHT
• H981088432050: ACIS IMPLANT CONVEX/STANDARD 5MM HEIGHT
• H981088431120: ACIS IMPLANT PARALLEL/STANDARD 12MM HEIGHT
• H981088431110: ACIS IMPLANT PARALLEL/STANDARD 11MM HEIGHT