TALOS° HA PEEK IBF

GUDID B167321520160

MEDITECH SPINE, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: B167321520160
• NIH Device Record Key: 4f6f66cf-97ac-46bb-8467-229c232aeae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALOS° HA PEEK IBF
• Version Model Number: 3-21520-16
• Company DUNS: 182698477
• Company Name: MEDITECH SPINE, LLC
• 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: true
• 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	B167321520160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170395

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: 2022-05-02
• Device Publish Date: 2022-04-22

On-Brand Devices [TALOS° HA PEEK IBF]

• B1676221719150: 6-221719-15
• B1676221719070: 6-221719-07
• B1676221719000: 6-221719-00
• B1676221718150: 6-221718-15
• B1676221718070: 6-221718-07
• B1676221718000: 6-221718-00
• B1676221717150: 6-221717-15
• B1676221717070: 6-221717-07
• B1676221717000: 6-221717-00
• B1676221716150: 6-221716-15
• B1676221716070: 6-221716-07
• B1676221716000: 6-221716-00
• B1676221715150: 6-221715-15
• B1676221715070: 6-221715-07
• B1676221715000: 6-221715-00
• B1676221714150: 6-221714-15
• B1676221714070: 6-221714-07
• B1676221714000: 6-221714-00
• B1676221713150: 6-221713-15
• B1676221713070: 6-221713-07
• B1676221713000: 6-221713-00
• B1676221712150: 6-221712-15
• B1676221712070: 6-221712-07
• B1676221712000: 6-221712-00
• B1676221711150: 6-221711-15
• B1676221711070: 6-221711-07
• B1676221711000: 6-221711-00
• B1676221710150: 6-221710-15
• B1676221710070: 6-221710-07
• B1676221710000: 6-221710-00
• B1676221709150: 6-221709-15
• B1676221709070: 6-221709-07
• B1676221709000: 6-221709-00
• B1676221708150: 6-221708-15
• B1676221708070: 6-221708-07
• B1676221708000: 6-221708-00
• B1676221707150: 6-221707-15
• B1676221707070: 6-221707-07
• B1676221707000: 6-221707-00
• B1676221619150: 6-221619-15
• B1676221619070: 6-221619-07
• B1676221619000: 6-221619-00
• B1676221618150: 6-221618-15
• B1676221618070: 6-221618-07
• B1676221618000: 6-221618-00
• B1676221617150: 6-221617-15
• B1676221617070: 6-221617-07
• B1676221617000: 6-221617-00
• B1676221616150: 6-221616-15
• B1676221616070: 6-221616-07