Stabilis

GUDID 00810161110995

Stabilis NF Ti Cervical Interbody 20x16x7 5°, STERILE

ACUITY SURGICAL DEVICES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00810161110995
• NIH Device Record Key: 1c25ab33-132f-4872-a351-8cdbaa864ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stabilis
• Version Model Number: 30-20160705-SP
• Company DUNS: 025855111
• Company Name: ACUITY SURGICAL DEVICES, LLC
• Device Count: 1
• DM Exempt: true
• 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: 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: 8442284890
• Email: support@acuitysurgical.com
• Phone: 8442284890
• Email: support@acuitysurgical.com
• Phone: 8442284890
• Email: support@acuitysurgical.com
• Phone: 8442284890
• Email: support@acuitysurgical.com
• Phone: 8442284890
• Email: support@acuitysurgical.com
• Phone: 8442284890
• Email: support@acuitysurgical.com

Device Dimensions

• Length: 20 Millimeter
• Width: 16 Millimeter
• Height: 7 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Width: 16 Millimeter
• Height: 7 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Width: 16 Millimeter
• Height: 7 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Width: 16 Millimeter
• Height: 7 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Width: 16 Millimeter
• Height: 7 Millimeter
• Angle: 5 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810161110995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230639

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [Stabilis]

• 00810161110759: Stabilis NF Ti Cervical Interbody 16x14x12 15°, STERILE
• 00810161110742: Stabilis NF Ti Cervical Interbody 16x14x12 10°, STERILE
• 00810161110735: Stabilis NF Ti Cervical Interbody 16x14x12 5°, STERILE
• 00810161110728: Stabilis NF Ti Cervical Interbody 16x14x11 15°, STERILE
• 00810161110711: Stabilis NF Ti Cervical Interbody 16x14x11 10°, STERILE
• 00810161110704: Stabilis NF Ti Cervical Interbody 16x14x11 5°, STERILE
• 00810161110698: Stabilis NF Ti Cervical Interbody 16x14x10 15°, STERILE
• 00810161110681: Stabilis NF Ti Cervical Interbody 16x14x10 10°, STERILE
• 00810161110674: Stabilis NF Ti Cervical Interbody 16x14x10 5°, STERILE
• 00810161110667: Stabilis NF Ti Cervical Interbody 16x14x9 15°, STERILE
• 00810161110650: Stabilis NF Ti Cervical Interbody 16x14x9 10°, STERILE
• 00810161110643: Stabilis NF Ti Cervical Interbody 16x14x9 5°, STERILE
• 00810161110636: Stabilis NF Ti Cervical Interbody 16x14x8 15°, STERILE
• 00810161110629: Stabilis NF Ti Cervical Interbody 16x14x8 10°, STERILE
• 00810161110612: Stabilis NF Ti Cervical Interbody 16x14x8 5°, STERILE
• 00810161110605: Stabilis NF Ti Cervical Interbody 16x14x7 15°, STERILE
• 00810161110599: Stabilis NF Ti Cervical Interbody 16x14x7 10°, STERILE
• 00810161110582: Stabilis NF Ti Cervical Interbody 16x14x7 5°, STERILE
• 00810161110575: Stabilis NF Ti Cervical Interbody 16x14x6 10°, STERILE
• 00810161110568: Stabilis NF Ti Cervical Interbody 16x14x6 5°, STERILE
• 00810161110551: Stabilis NF Ti Cervical Interbody 16x14x5 5°, STERILE
• 00810161110544: Stabilis NF Ti Cervical Interbody 14x12x12 15°, STERILE
• 00810161110537: Stabilis NF Ti Cervical Interbody 14x12x12 10°, STERILE
• 00810161110520: Stabilis NF Ti Cervical Interbody 14x12x12 5°, STERILE
• 00810161110513: Stabilis NF Ti Cervical Interbody 14x12x11 15°, STERILE
• 00810161110506: Stabilis NF Ti Cervical Interbody 14x12x11 10°, STERILE
• 00810161110490: Stabilis NF Ti Cervical Interbody 14x12x11 5°, STERILE
• 00810161110483: Stabilis NF Ti Cervical Interbody 14x12x10 15°, STERILE
• 00810161110476: Stabilis NF Ti Cervical Interbody 14x12x10 10°, STERILE
• 00810161110469: Stabilis NF Ti Cervical Interbody 14x12x10 5°, STERILE
• 00810161110452: Stabilis NF Ti Cervical Interbody 14x12x9 15°, STERILE
• 00810161110445: Stabilis NF Ti Cervical Interbody 14x12x9 10°, STERILE
• 00810161110438: Stabilis NF Ti Cervical Interbody 14x12x9 5°, STERILE
• 00810161110421: Stabilis NF Ti Cervical Interbody 14x12x8 15°, STERILE
• 00810161110414: Stabilis NF Ti Cervical Interbody 14x12x8 10°, STERILE
• 00810161110407: Stabilis NF Ti Cervical Interbody 14x12x8 5°, STERILE
• 00810161110391: Stabilis NF Ti Cervical Interbody 14x12x7 15°, STERILE
• 00810161110384: Stabilis NF Ti Cervical Interbody 14x12x7 10°, STERILE
• 00810161110377: Stabilis NF Ti Cervical Interbody 14x12x7 5°, STERILE
• 00810161110360: Stabilis NF Ti Cervical Interbody 14x12x6 10°, STERILE
• 00810161110353: Stabilis NF Ti Cervical Interbody 14x12x6 5°, STERILE
• 00810161110346: Stabilis NF Ti Cervical Interbody 14x12x5 5°, STERILE
• 00810161112234: Stabilis NF Ti Cervical Interbody 18x15x5 5°, STERILE
• 00810161111169: Stabilis NF Ti Cervical Interbody 20x16x12 15°, STERILE
• 00810161111152: Stabilis NF Ti Cervical Interbody 20x16x12 10°, STERILE
• 00810161111145: Stabilis NF Ti Cervical Interbody 20x16x12 5°, STERILE
• 00810161111138: Stabilis NF Ti Cervical Interbody 20x16x11 15°, STERILE
• 00810161111121: Stabilis NF Ti Cervical Interbody 20x16x11 10°, STERILE
• 00810161111114: Stabilis NF Ti Cervical Interbody 20x16x11 5°, STERILE
• 00810161111107: Stabilis NF Ti Cervical Interbody 20x16x10 15°, STERILE