EquiLOX Lumbar Expandable Cage

GUDID 00850065741345

Expandable Lumbar Cage 32mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)

CAPTIVA SPINE, INC.

Spinal fusion sphere

• Primary Device ID: 00850065741345
• NIH Device Record Key: 4a3b0233-e01b-448a-9bbd-2f4ec458fd59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EquiLOX Lumbar Expandable Cage
• Version Model Number: CSF0301-B0032A743S
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, INC.
• 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: 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: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065741345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232069

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2024-12-02
• Device Publish Date: 2024-11-22

On-Brand Devices [EquiLOX Lumbar Expandable Cage]

• 00850065741222: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 13mm (H1) - 18mm (H2) x 15deg (LA)
• 00850065741215: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 12deg (LA)
• 00850065741208: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 9deg (LA)
• 00850065741192: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 6deg (LA)
• 00850065741185: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 9mm (H1) - 13mm (H2) x 3deg (LA)
• 00850065741178: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA)
• 00850065741161: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 12deg (LA)
• 00850065741154: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 9deg (LA)
• 00850065741147: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 9mm (H1) - 14mm (H2) x 6deg (LA)
• 00850065741130: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA)
• 00850065741123: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA)
• 00850065741116: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 12deg (LA)
• 00850065741109: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 9deg (LA)
• 00850065741093: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 9mm (H1) - 14mm (H2) x 6deg (LA)
• 00850065741086: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA)
• 00850065741345: Expandable Lumbar Cage 32mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
• 00850065741338: Expandable Lumbar Cage 28mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
• 00850065741321: Expandable Lumbar Cage 24mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)