Ti-Diagon Oblique TLIF

GUDID B030DIT281115160

TLIF Implant, 28mm x 11mm, 16mm, 15° Lordotic

CAMBER SPINE TECHNOLOGIES, LLC

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile

• Primary Device ID: B030DIT281115160
• NIH Device Record Key: 207136df-d39f-4181-a038-02773afbe762
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti-Diagon Oblique TLIF
• Version Model Number: DIT-2811-1516
• Company DUNS: 054205979
• Company Name: CAMBER SPINE TECHNOLOGIES, 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: true
• 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

Customer Support Contacts

• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com
• Phone: 1-866-643-0739
• Email: customerservice@cambermedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B030DIT281115160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172064

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B030DIT281115160]

Moist Heat or Steam Sterilization

[B030DIT281115160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-05
• Device Publish Date: 2018-04-20

On-Brand Devices [Ti-Diagon Oblique TLIF]

• B030DIT281115180: TLIF Implant, 28mm x 11mm, 18mm, 15° Lordotic
• B030DIT281115170: TLIF Implant, 28mm x 11mm, 17mm, 15° Lordotic
• B030DIT281115160: TLIF Implant, 28mm x 11mm, 16mm, 15° Lordotic
• B030DIT281115150: TLIF Implant, 28mm x 11mm, 15mm, 15° Lordotic
• B030DIT281115140: TLIF Implant, 28mm x 11mm, 14mm, 15° Lordotic
• B030DIT281115130: TLIF Implant, 28mm x 11mm, 13mm, 15° Lordotic
• B030DIT281115120: TLIF Implant, 28mm x 11mm, 12mm, 15° Lordotic
• B030DIT281108180: TLIF Implant, 28mm x 11mm, 18mm, 8° Lordotic
• B030DIT281108170: TLIF Implant, 28mm x 11mm, 17mm, 8° Lordotic
• B030DIT281108160: TLIF Implant, 28mm x 11mm, 16mm, 8° Lordotic
• B030DIT281108150: TLIF Implant, 28mm x 11mm, 15mm, 8° Lordotic
• B030DIT281108140: TLIF Implant, 28mm x 11mm, 14mm, 8° Lordotic
• B030DIT281108130: TLIF Implant, 28mm x 11mm, 13mm, 8° Lordotic
• B030DIT281108120: TLIF Implant, 28mm x 11mm, 12mm, 8° Lordotic
• B030DIT281108110: TLIF Implant, 28mm x 11mm, 11mm, 8° Lordotic
• B030DIT281108100: TLIF Implant, 28mm x 11mm, 10mm, 8° Lordotic
• B030DIT261115180: TLIF Implant, 26mm x 11mm, 18mm, 15° Lordotic
• B030DIT261115170: TLIF Implant, 26mm x 11mm, 17mm, 15° Lordotic
• B030DIT261115160: TLIF Implant, 26mm x 11mm, 16mm, 15° Lordotic
• B030DIT261115150: TLIF Implant, 26mm x 11mm, 15mm, 15° Lordotic
• B030DIT261115140: TLIF Implant, 26mm x 11mm, 14mm, 15° Lordotic
• B030DIT261115130: TLIF Implant, 26mm x 11mm, 13mm, 15° Lordotic
• B030DIT261115120: TLIF Implant, 26mm x 11mm, 12mm, 15° Lordotic
• B030DIT261115110: TLIF Implant, 26mm x 11mm, 11mm, 15° Lordotic
• B030DIT261108180: TLIF Implant, 26mm x 11mm, 18mm, 8° Lordotic
• B030DIT261108170: TLIF Implant, 26mm x 11mm, 17mm, 8° Lordotic
• B030DIT261108160: TLIF Implant, 26mm x 11mm, 16mm, 8° Lordotic
• B030DIT261108150: TLIF Implant, 26mm x 11mm, 15mm, 8° Lordotic
• B030DIT261108140: TLIF Implant, 26mm x 11mm, 14mm, 8° Lordotic
• B030DIT261108130: TLIF Implant, 26mm x 11mm, 13mm, 8° Lordotic
• B030DIT261108120: TLIF Implant, 26mm x 11mm, 12mm, 8° Lordotic
• B030DIT261108110: TLIF Implant, 26mm x 11mm, 11mm, 8° Lordotic
• B030DIT261108100: TLIF Implant, 26mm x 11mm, 10mm, 8° Lordotic
• B030DIT261108090: TLIF Implant, 26mm x 11mm, 9mm, 8° Lordotic
• B030DIT221115180: TLIF Implant, 22mm x 11mm, 18mm, 15° Lordotic
• B030DIT221115170: TLIF Implant, 22mm x 11mm, 17mm, 15° Lordotic
• B030DIT221115160: TLIF Implant, 22mm x 11mm, 16mm, 15° Lordotic
• B030DIT221115150: TLIF Implant, 22mm x 11mm, 15mm, 15° Lordotic
• B030DIT221115140: TLIF Implant, 22mm x 11mm, 14mm, 15° Lordotic
• B030DIT221115130: TLIF Implant, 22mm x 11mm, 13mm, 15° Lordotic
• B030DIT221115120: TLIF Implant, 22mm x 11mm, 12mm, 15° Lordotic
• B030DIT221115110: TLIF Implant, 22mm x 11mm, 11mm, 15° Lordotic
• B030DIT221115100: TLIF Implant, 22mm x 11mm, 10mm, 15° Lordotic
• B030DIT221108180: TLIF Implant, 22mm x 11mm, 18mm, 8° Lordotic
• B030DIT221108170: TLIF Implant, 22mm x 11mm, 17mm, 8° Lordotic
• B030DIT221108160: TLIF Implant, 22mm x 11mm, 16mm, 8° Lordotic
• B030DIT221108150: TLIF Implant, 22mm x 11mm, 15mm, 8° Lordotic
• B030DIT221108140: TLIF Implant, 22mm x 11mm, 14mm, 8° Lordotic
• B030DIT221108130: TLIF Implant, 22mm x 11mm, 13mm, 8° Lordotic
• B030DIT221108120: TLIF Implant, 22mm x 11mm, 12mm, 8° Lordotic