TransFasten - LSF, K-wire

GUDID M73910290160

K-wire

CAPTIVA SPINE, INC.

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: M73910290160
• NIH Device Record Key: b0f86325-a789-48f2-bb4d-8b9c1162dd94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransFasten - LSF, K-wire
• Version Model Number: 10-2-9016
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Dimensions

• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter
• Length: 457 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M73910290160 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

[M73910290160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-03
• Device Publish Date: 2024-04-25

Devices Manufactured by CAPTIVA SPINE, INC.

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• 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