12(w) x 15(d) Saber-C Bodies (Titanium) CBT-2567

GUDID 00810017910922

Saber-C Body (T), 12x15x7 6 deg.

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00810017910922
• NIH Device Record Key: 7fad41ca-2e49-40a6-9832-a68c8fa864db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12(w) x 15(d) Saber-C Bodies (Titanium)
• Version Model Number: CBT-2567
• Catalog Number: CBT-2567
• Company DUNS: 085718404
• Company Name: ELEVATION SPINE, INC.
• 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: 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
GS1	00810017910922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190885

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

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: 2019-11-19
• Device Publish Date: 2019-11-11

On-Brand Devices [12(w) x 15(d) Saber-C Bodies (Titanium)]

• 00810017910922: Saber-C Body (T), 12x15x7 6 deg.
• 00810017910885: Saber-C Body (T), 12x15x9 0 deg.
• 00810017910878: Saber-C Body (T), 12x15x8 0 deg.
• 00810017910861: Saber-C Body (T), 12x15x7 0 deg.
• 00810017910854: Saber-C Body (T), 12x15x6 0 deg.
• 00810017910847: Saber-C Body (T), 12x15x5 0 deg.
• 00810017911004: Saber-C Body (T), 12x15x9 9 deg.
• 00810017910991: Saber-C Body (T), 12x15x8 9 deg.
• 00810017910984: Saber-C Body (T), 12x15x7 9 deg.
• 00810017910977: Saber-C Body (T), 12x15x6 9 deg.
• 00810017910960: Saber-C Body (T), 12x15x5 9 deg.
• 00810017910953: Saber-C Body (T), 12x15x10 6 deg.
• 00810017910946: Saber-C Body (T), 12x15x9 6 deg.
• 00810017910939: Saber-C Body (T), 12x15x8 6 deg.
• 00810017910915: Saber-C Body (T), 12x15x6 6 deg.
• 00810017910908: Saber-C Body (T), 12x15x5 6 deg.
• 00810017910892: Saber-C Body (T), 12x15x10 0 deg.
• 00810017911011: Saber-C Body (T), 12x15x10 9 deg.