TALOS® HA PEEK IBF

GUDID B167321113200

MEDITECH SPINE, LLC

Polymeric spinal fusion cage, sterile

• Primary Device ID: B167321113200
• NIH Device Record Key: d8c6d637-6439-47d1-91bd-5f20cdc73502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALOS® HA PEEK IBF
• Version Model Number: 3-21113-20
• 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	B167321113200 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

On-Brand Devices [TALOS® HA PEEK IBF]

• B167322618110: 3-22618-11
• B167322617110: 3-22617-11
• B167322616110: 3-22616-11
• B167322615110: 3-22615-11
• B167322614110: 3-22614-11
• B167322613110: 3-22613-11
• B167322612110: 3-22612-11
• B167322611110: 3-22611-11
• B167322610110: 3-22610-11
• B167322609110: 3-22609-11
• B167322608110: 3-22608-11
• B167322518110: 3-22518-11
• B167322517110: 3-22517-11
• B167322516110: 3-22516-11
• B167322515110: 3-22515-11
• B167322514110: 3-22514-11
• B167322513110: 3-22513-11
• B167322512110: 3-22512-11
• B167322511110: 3-22511-11
• B167322510110: 3-22510-11
• B167322509110: 3-22509-11
• B167322508110: 3-22508-11
• B167322418110: 3-22418-11
• B167322417110: 3-22417-11
• B167322416110: 3-22416-11
• B167322415110: 3-22415-11
• B167322414110: 3-22414-11
• B167322413110: 3-22413-11
• B167322412110: 3-22412-11
• B167322411110: 3-22411-11
• B167322410110: 3-22410-11
• B167322409110: 3-22409-11
• B167322408110: 3-22408-11
• B167322318110: 3-22318-11
• B167322317110: 3-22317-11
• B167322316110: 3-22316-11
• B167322315110: 3-22315-11
• B167322314110: 3-22314-11
• B167322313110: 3-22313-11
• B167322312110: 3-22312-11
• B167322311110: 3-22311-11
• B167322310110: 3-22310-11
• B167322309110: 3-22309-11
• B167322308110: 3-22308-11
• B167322218110: 3-22218-11
• B167322217110: 3-22217-11
• B167322216110: 3-22216-11
• B167322215110: 3-22215-11
• B167322214110: 3-22214-11
• B167322213110: 3-22213-11