TALOS® (HA) IBF

GUDID B167613271611070

MEDITECH SPINE, LLC

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: B167613271611070
• NIH Device Record Key: 83a33ba6-892c-4e14-a6dd-fad20e50a961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALOS® (HA) IBF
• Version Model Number: 613-271611-07
• 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: false
• Lot Batch: true
• Serial Number: true
• 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	B167613271611070 [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: true
• Device Is Sterile: false

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

[B167613271611070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2020-03-26

On-Brand Devices [TALOS® (HA) IBF]

• B167600427000: 600-427-00
• B167613271719150: 613-271719-15
• B167613271719070: 613-271719-07
• B167613271719000: 613-271719-00
• B167613271718150: 613-271718-15
• B167613271718070: 613-271718-07
• B167613271718000: 613-271718-00
• B167613271717150: 613-271717-15
• B167613271717070: 613-271717-07
• B167613271717000: 613-271717-00
• B167613271716150: 613-271716-15
• B167613271716070: 613-271716-07
• B167613271716000: 613-271716-00
• B167613271715150: 613-271715-15
• B167613271715070: 613-271715-07
• B167613271715000: 613-271715-00
• B167613271714150: 613-271714-15
• B167613271714070: 613-271714-07
• B167613271714000: 613-271714-00
• B167613271713150: 613-271713-15
• B167613271713070: 613-271713-07
• B167613271713000: 613-271713-00
• B167613271712150: 613-271712-15
• B167613271712070: 613-271712-07
• B167613271712000: 613-271712-00
• B167613271711150: 613-271711-15
• B167613271711070: 613-271711-07
• B167613271711000: 613-271711-00
• B167613271710150: 613-271710-15
• B167613271710070: 613-271710-07
• B167613271710000: 613-271710-00
• B167613271709150: 613-271709-15
• B167613271709070: 613-271709-07
• B167613271709000: 613-271709-00
• B167613271708150: 613-271708-15
• B167613271708070: 613-271708-07
• B167613271708000: 613-271708-00
• B167613271707150: 613-271707-15
• B167613271707070: 613-271707-07
• B167613271707000: 613-271707-00
• B167613271619150: 613-271619-15
• B167613271619070: 613-271619-07
• B167613271619000: 613-271619-00
• B167613271618150: 613-271618-15
• B167613271618070: 613-271618-07
• B167613271618000: 613-271618-00
• B167613271617150: 613-271617-15
• B167613271617070: 613-271617-07
• B167613271617000: 613-271617-00
• B167613271616150: 613-271616-15