TALOS®-C

GUDID B16750008161407A0

MEDITECH SPINE, LLC

Spinal implant trial

• Primary Device ID: B16750008161407A0
• NIH Device Record Key: 58625b6b-c6b3-4232-83a8-c6af3d3170ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TALOS®-C
• Version Model Number: 500-081614-07-A
• 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	B16750008161407A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142345

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[B16750008161407A0]

Moist Heat or Steam Sterilization

[B16750008161407A0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-10

On-Brand Devices [TALOS®-C]

• B167530205000: 530-205-00
• B167530200000: 530-200-00
• B167520205550: 520-205-55
• B167520205510: 520-205-51
• B167520205500: 520-205-50
• B167520205000: 520-205-00
• B167520200000: 520-200-00
• B1675151203000: 515-120300
• B1675151202000: 515-120200
• B1675151201000: 515-120100
• B167512201407A0: 5-122014-07-A
• B1675122014070: 5-122014-07
• B167512201400A0: 5-122014-00-A
• B1675122014000: 5-122014-00
• B167512181507A0: 5-121815-07-A
• B1675121815070: 5-121815-07
• B167512181500A0: 5-121815-00-A
• B1675121815000: 5-121815-00
• B167512181307A0: 5-121813-07-A
• B1675121813070: 5-121813-07
• B167512181300A0: 5-121813-00-A
• B1675121813000: 5-121813-00
• B167512181207A0: 5-121812-07-A
• B1675121812070: 5-121812-07
• B167512181200A0: 5-121812-00-A
• B1675121812000: 5-121812-00
• B167512161407A0: 5-121614-07-A
• B1675121614070: 5-121614-07
• B167512161400A0: 5-121614-00-A
• B1675121614000: 5-121614-00
• B167512141207A0: 5-121412-07-A
• B1675121412070: 5-121412-07
• B167512141200A0: 5-121412-00-A
• B1675121412000: 5-121412-00
• B167512121207A0: 5-121212-07-A
• B1675121212070: 5-121212-07
• B167512121200A0: 5-121212-00-A
• B1675121212000: 5-121212-00
• B167511201407A0: 5-112014-07-A
• B1675112014070: 5-112014-07
• B167511201400A0: 5-112014-00-A
• B1675112014000: 5-112014-00
• B167511181507A0: 5-111815-07-A
• B1675111815070: 5-111815-07
• B167511181500A0: 5-111815-00-A
• B1675111815000: 5-111815-00
• B167511181307A0: 5-111813-07-A
• B1675111813070: 5-111813-07
• B167511181300A0: 5-111813-00-A
• B1675111813000: 5-111813-00