Lordotic Cage, 32 x 11mm

GUDID M739FPL3211

Lordotic Cage, 32 x 11mm

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M739FPL3211
• NIH Device Record Key: ec571598-e218-437b-98e3-dbac74c9976c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lordotic Cage, 32 x 11mm
• Version Model Number: FPL3211
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M739FPL3211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122956

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M739FPL3211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-30

Devices Manufactured by CAPTIVA SPINE, INC.

• 00850065741321 - EquiLOX Lumbar Expandable Cage: 2024-12-02 Expandable Lumbar Cage 24mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
• 00850065741338 - EquiLOX Lumbar Expandable Cage: 2024-12-02 Expandable Lumbar Cage 28mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
• 00850065741345 - EquiLOX Lumbar Expandable Cage: 2024-12-02 Expandable Lumbar Cage 32mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
• 00850065741352 - EquiLOX Lumbar Expandable Cage - Graft Impactor: 2024-12-02 Graft Impactor
• 00850065741369 - EquiLOX Lumbar Expandable Cage - Bone Graft Funnel: 2024-12-02 Bone Graft Funnel
• 00850065741376 - EquiLOX Lumbar Expandable Cage - Holder shaft: 2024-12-02 Cage Holder - Retention Rod Center Shaft
• 00850065741000 - EquiLOX Lumbar Expandable Cage - Bone Impactor: 2024-07-24 Bone impactor
• 00850065741017 - EquiLOX Lumbar Expandable Cage - Funnel: 2024-07-24 Funnel