A Link Z

GUDID 00810043481847

Ø27mm x 17mm x 20° FRA Trial

ACUITY SURGICAL DEVICES, LLC

Spinal implant trial

• Primary Device ID: 00810043481847
• NIH Device Record Key: d4b89a0c-e4cd-41a4-8a37-2adacce62fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A Link Z
• Version Model Number: 10-277170
• 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: false
• 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: 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
• 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
• 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

• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree
• Outer Diameter: 27 Millimeter
• Height: 17 Millimeter
• Angle: 20 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810043481847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201671

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

[00810043481847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [A Link Z]

• 00856037005996: A Link Z Ti Unitary Interbody 36x26x17 12°
• 00856037005897: A Link Z Ti Unitary Interbody 32x21x15 7°
• 00856037005880: A Link Z Ti Unitary Interbody 32x21x13 12°
• 00856037005873: A Link Z Ti Unitary Interbody 32x21x13 7°
• 00856037005866: A Link Z Ti Unitary Interbody 32x21x11 12°
• 00856037005859: A Link Z Ti Unitary Interbody 32x21x11 7°
• 00856037005705: A Link Z Plate 32x28x17 12°
• 00856037005699: A Link Z Plate 32x28x15 7°
• 00856037005682: A Link Z Plate 32x28x15 12°
• 00856037005675: A Link Z Plate 32x28x13 7°
• 00856037005668: A Link Z Plate 32x28x13 12°
• 00856037005644: A Link Z Plate 32x28x11 12°
• 00856037005569: Cover Plate Assembly
• 00856037005545: A Link Z Screw 5.5mm x 25mm T20
• 00856037005538: A Link Z Screw 5.5mm x 20mm T20
• 00856037005521: A Link Z Screw 5.0mm x 30mm T20
• 00856037005514: A Link Z Screw 5.0mm x 25mm T20
• 00856037005507: A Link Z Screw 5.0mm x 20mm T20
• 00850812008912: A Link Z Ti Unitary FRA Interbody 27x18 12°
• 00850812008905: A Link Z Ti Unitary FRA Interbody 27x18 7°
• 00850812008899: A Link Z Ti Unitary FRA Interbody 27x16 12°
• 00850812008882: A Link Z Ti Unitary FRA Interbody 27x16 7°
• 00850812008875: A Link Z Ti Unitary FRA Interbody 27x14 12°
• 00850812008868: A Link Z Ti Unitary FRA Interbody 27x14 7°
• 00850812008851: A Link Z Ti Unitary FRA Interbody 27x12 12°
• 00850812008844: A Link Z Ti Unitary FRA Interbody 27x12 7°
• 00850812008837: A Link Z Ti Unitary FRA Interbody 27x10 12°
• 00850812008820: A Link Z Ti Unitary FRA Interbody 27x10 7°
• 00850812008547: A Link Z Ti Unitary FRA Interbody 27x17 12°
• 00850812008516: FRA Cover Plate Assembly
• 00850812008509: A Link Z Ti Unitary FRA Interbody 27x17 7°
• 00850812008493: A Link Z Ti Unitary FRA Interbody 27x15 12°
• 00850812008486: A Link Z Ti Unitary FRA Interbody 27x15 7°
• 00850812008479: A Link Z Ti Unitary FRA Interbody 27x13 12°
• 00850812008462: A Link Z Ti Unitary FRA Interbody 27x13 7°
• 00850812008455: A Link Z Ti Unitary FRA Interbody 27x11 12°
• 00850812008448: A Link Z Ti Unitary FRA Interbody 27x11 7°
• 00850812008431: A Link Z Ti Unitary FRA Interbody 27x9 12°
• 00850812008424: A Link Z Ti Unitary FRA Interbody 27x9 7°
• 00850812008219: A Link Z Ti Unitary Interbody 32x21x13 20°
• 00850812008202: A Link Z Ti Unitary Interbody 32x21x13 16°
• 00850812008127: A Link Z Ti Unitary Interbody 36x26x17 20°
• 00850812008110: A Link Z Ti Unitary Interbody 36x26x17 16°
• 00810043480994: A Link Z Ti Unitary Open Interbody 32x24x19 12°
• 00810043480970: A Link Z Ti Unitary Open Interbody 32x24x18 12°
• 00810043480963: A Link Z Ti Unitary Open Interbody 32x24x18 7°
• 00810043480581: Far AL Compact Implant Retainer
• 00810043480574: Far AL Inserter
• 00810043480567: Large Angle Far AL Oblique Implant Retainer
• 00810043480550: Small Angle Far AL Oblique Implant Retainer