ACIS 08843311

GUDID H981088433110

ACIS IMPLANT LORDOTIC/LARGE 11MM HEIGHT

SYNTHES (U.S.A.) LP

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 Polymeric spinal interbody fusion cage

• Primary Device ID: H981088433110
• NIH Device Record Key: f5d46e92-d72c-4605-bb7a-0f9c62f1d51c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIS
• Version Model Number: 08.843.311
• Catalog Number: 08843311
• 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	10705034762173 [Primary]
HIBCC	H981088433110 [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

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

Moist Heat or Steam Sterilization

[H981088433110]

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