TLIF Straight, 28 x 16mm

GUDID M739PS28160

CAPTIVA SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M739PS28160
• NIH Device Record Key: a546715b-44d4-4804-b7e3-4afd70beb3ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLIF Straight, 28 x 16mm
• Version Model Number: PS2816
• 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	M739PS28160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092017

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M739PS28160]

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: 2017-08-11

On-Brand Devices [TLIF Straight, 28 x 16mm]

• M739PS28160: PS2816
• M739PS2816: TLIF Straight, 28 x 16mm