ProAM ALIF System LN-010610-0000

GUDID 00810152902615

Lock Driver

Pro Surgical, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 00810152902615
• NIH Device Record Key: 12fc9b81-6701-4ce2-a79a-362c8e6fa090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProAM ALIF System
• Version Model Number: LN-010610-0000
• Catalog Number: LN-010610-0000
• Company DUNS: 119149675
• Company Name: Pro Surgical, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810152902615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240126

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

[00810152902615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [ProAM ALIF System]

• 00810152900017: Fixated ALIF 3-Hole - 34mm x 25mm x 12mm, 6°
• 00810152900000: Fixated ALIF 3-Hole - 34mm x 25mm x 10mm, 6°
• 00810152900024: Fixated ALIF 3-Hole - 34mm x 25mm x 14mm, 6°
• 00810152903049: Implant & Trial Caddy Lid - 42 x 29mm 18°
• 00810152903032: Implant & Trial Caddy Base - 42 x 29mm 18°
• 00810152903025: Implant & Trial Caddy - 42 x 29mm 18°
• 00810152903018: Implant & Trial Caddy Lid - 38 x 27mm 18°
• 00810152903001: Implant & Trial Caddy Base - 38 x 27mm 18°
• 00810152902998: Implant & Trial Caddy - 38 x 27mm 18°
• 00810152902981: Implant & Trial Caddy Lid - 34 x 25mm 18°
• 00810152902974: Implant & Trial Caddy Base - 34 x 25mm 18°
• 00810152902967: Implant & Trial Caddy - 34 x 25mm 18°
• 00810152902950: Implant & Trial Caddy Lid - 42 x 29mm 12°
• 00810152902943: Implant & Trial Caddy Base - 42 x 29mm 12°
• 00810152902936: Implant & Trial Caddy - 42 x 29mm 12°
• 00810152902929: Implant & Trial Caddy Lid - 38 x 27mm 12°
• 00810152902912: Implant & Trial Caddy Base - 38 x 27mm 12°
• 00810152902905: FImplant & Trial Caddy - 38 x 27mm 12°
• 00810152902899: Implant & Trial Caddy Lid - 34 x 25mm 12°
• 00810152902882: Implant & Trial Caddy Base - 34 x 25mm 12°
• 00810152902875: Implant & Trial Caddy - 34 x 25mm 12°
• 00810152902868: Implant & Trial Caddy Lid - 42 x 29mm 6°
• 00810152902851: Implant & Trial Caddy Base - 42 x 29mm 6°
• 00810152902844: Implant & Trial Caddy - 42 x 29mm 6°
• 00810152902837: Implant & Trial Caddy Lid - 38 x 27mm 6°
• 00810152902820: Implant & Trial Caddy Base - 38 x 27mm 6°
• 00810152902813: Implant & Trial Caddy - 38 x 27mm 6°
• 00810152902806: Implant & Trial Caddy Lid - 34 x 25mm 6°
• 00810152902790: Implant & Trial Caddy Base - 34 x 25mm 6°
• 00810152902783: Implant & Trial Caddy - 34 x 25mm 6°
• 00810152902776: ALIF Implant & Trial Tray 2 Lid
• 00810152902769: ALIF Implant & Trial Tray 2 Base
• 00810152902752: ALIF Implant & Trial Tray 2
• 00810152902745: ALIF Implant & Trial Tray Insert
• 00810152902738: ALIF Implant & Trial Tray 1 Lid
• 00810152902721: ALIF Implant & Trial Tray 1 Base
• 00810152902714: ALIF Implant & Trial Tray 1
• 00810152902707: Screw Caddy Lid
• 00810152902691: Screw Caddy Base
• 00810152902684: Screw Caddy
• 00810152902677: ALIF Instrument & Screw Tray Insert
• 00810152902660: ALIF Instrument & Screw Tray Lid
• 00810152902653: ALIF Instrument & Screw Tray Base
• 00810152902646: ALIF Instrument & Screw Tray
• 00810152902448: ALIF Trial - 42mm x 29mm x 20mm, 18°
• 00810152902431: ALIF Trial - 42mm x 29mm x 18mm, 18°
• 00810152902424: ALIF Trial - 42mm x 29mm x 16mm, 18°
• 00810152902417: ALIF Trial - 42mm x 29mm x 14mm, 18°
• 00810152902400: ALIF Trial - 42mm x 29mm x 12mm, 18°
• 00810152902394: ALIF Trial - 42mm x 29mm x 10mm, 18°