Sage Cervical Interbody Fusion System

GUDID B648C20412110870

PEEK Cervical Spacer, 12 x 11 x 8mm, 7 deg

CURITEVA, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: B648C20412110870
• NIH Device Record Key: 36685901-857e-4086-b3f1-7d6e41bfc92e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sage Cervical Interbody Fusion System
• Version Model Number: C204-121108-7
• Company DUNS: 074575332
• Company Name: CURITEVA, 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: 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

Customer Support Contacts

• Phone: +1 (877) 928-7483
• Email: support@curiteva.com

Device Dimensions

• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B648C20412110870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181261

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B648C20412110870]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-08-15

On-Brand Devices [Sage Cervical Interbody Fusion System]

• B648C20418141270: PEEK Cervical Spacer, 18 x 14 x 12mm, 7 deg
• B648C20418141170: PEEK Cervical Spacer, 18 x 14 x 11mm, 7 deg
• B648C20418141070: PEEK Cervical Spacer, 18 x 14 x 10mm, 7 deg
• B648C20418140970: PEEK Cervical Spacer, 18 x 14 x 9mm, 7 deg
• B648C20418140870: PEEK Cervical Spacer, 18 x 14 x 8mm, 7 deg
• B648C20418140770: PEEK Cervical Spacer, 18 x 14 x 7mm, 7 deg
• B648C20418140670: PEEK Cervical Spacer, 18 x 14 x 6mm, 7 deg
• B648C20418140570: PEEK Cervical Spacer, 18 x 14 x 5mm, 7 deg
• B648C20414121270: PEEK Cervical Spacer, 14 x 12 x 12mm, 7 deg
• B648C20414121170: PEEK Cervical Spacer, 14 x 12 x 11mm, 7 deg
• B648C20414121070: PEEK Cervical Spacer, 14 x 12 x 10mm, 7 deg
• B648C20414120970: PEEK Cervical Spacer, 14 x 12 x 9mm, 7 deg
• B648C20414120870: PEEK Cervical Spacer, 14 x 12 x 8mm, 7 deg
• B648C20414120770: PEEK Cervical Spacer, 14 x 12 x 7mm, 7 deg
• B648C20414120670: PEEK Cervical Spacer, 14 x 12 x 6mm, 7 deg
• B648C20414120570: PEEK Cervical Spacer, 14 x 12 x 5mm, 7 deg
• B648C2241814127CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 12mm, 7 deg
• B648C2241814117CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 11mm, 7 deg
• B648C2241814107CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 10mm, 7 deg
• B648C2241814097CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 9mm, 7 deg
• B648C2241814087CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 8mm, 7 deg
• B648C2241814077CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 7mm, 7 deg
• B648C2241814067CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 6mm, 7 deg
• B648C2241814057CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 18 x 14 x 5mm, 7 deg
• B648C2241613127CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 12mm, 7 deg
• B648C2241613117CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 11mm, 7 deg
• B648C2241613107CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 10mm, 7 deg
• B648C2241613097CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 9mm, 7 deg
• B648C2241613087CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 8mm, 7 deg
• B648C2241613077CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 7mm, 7 deg
• B648C2241613067CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 6mm, 7 deg
• B648C2241613057CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 5mm, 7 deg
• B648C2241412127CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 12mm, 7 deg
• B648C2241412117CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 11mm, 7 deg
• B648C2241412107CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 10mm, 7 deg
• B648C2241412097CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 9mm, 7 deg
• B648C2241412087CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 8mm, 7 deg
• B648C2241412077CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 7mm, 7 deg
• B648C2241412067CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 6mm, 7 deg
• B648C2241412057CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 14 x 12 x 5mm, 7 deg
• B648C2241211127CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 12mm, 7 deg
• B648C2241211117CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 11mm, 7 deg
• B648C2241211107CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 10mm, 7 deg
• B648C2241211097CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 9mm, 7 deg
• B648C2241211087CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 8mm, 7 deg
• B648C2241211077CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 7mm, 7 deg
• B648C2241211067CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 6mm, 7 deg
• B648C2241211057CT0: PEEK Cervical Spacer with Titanium Plasma Coating, 12 x 11 x 5mm, 7 deg
• B648C21418141270: Titanium Cervical Spacer, 18 x 14 x 12mm, 7 deg
• B648C21418141170: Titanium Cervical Spacer, 18 x 14 x 11mm, 7 deg