Toro-L ASY-00504

GUDID 00810004729582

50mm Expandable Width Trial

Integrity Implants Inc.

Spinal implant trial

• Primary Device ID: 00810004729582
• NIH Device Record Key: fd921a2b-adf8-4033-b1eb-a08a2f91bca1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toro-L
• Version Model Number: ASY-00504
• Catalog Number: ASY-00504
• Company DUNS: 080300717
• Company Name: Integrity Implants Inc.
• Device Count: 1
• DM Exempt: false
• 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: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004729582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213355

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

[00810004729582]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

On-Brand Devices [Toro-L]

• 00840200408608: V1 Toro-L 10° 14mm-24mm x 60mm
• 00840200408592: V1 Toro-L 10° 14mm-24mm x 55mm
• 00840200408585: V1 Toro-L 10° 14mm-24mm x 50mm
• 00810004729650: Secondary Retention Rod
• 00810004729643: Actuator Driver
• 00810004729636: Inserter Cap
• 00810004729629: Primary Retention Rod
• 00810004729612: Assembly, Lateral Inserter
• 00084020040857: V1 Toro-L 10° 14mm-24mm x 45mm
• 00840200408578: V1 Toro-L 10° 14mm-24mm x 45mm
• 00840200409162: 60mm Locking Rod
• 00840200409155: 55mm Locking Rod
• 00840200409148: 50mm Locking Rod
• 00840200409131: 45mm Locking Rod
• 00840200408684: Toro-L Inserter
• 00840200404648: Expansion Driver
• 00840200404631: Attachment Rod
• 00840200404624: 60mm Expansion Rod
• 00840200404617: 55mm Expansion Rod
• 00840200404600: 50mm Expansion Rod
• 00840200404594: 45mm Expansion Rod
• 00840200404037: Toro- L Graft Tube
• 00810045539003: 60mm Expandable Height Trial
• 00810004729605: 60mm Expandable Width Trial
• 00810004729599: 55mm Expandable Width Trial
• 00810004729582: 50mm Expandable Width Trial
• 00810004729575: 45mm Expandable Width Trial
• 00840200403016: Toro-L 10° x 14mm-24mm x 60mm
• 00840200403009: Toro-L 10° x 14mm-24mm x 55mm
• 00840200402996: Toro-L 10° x 14mm-24mm x 50mm
• 00840200402989: Toro-L 10° x 14mm-24mm x 45mm