Rebar® SCC-001-011

GUDID M681SCC0010111

11mm Lordotic Spacer

ATLAS SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M681SCC0010111
• NIH Device Record Key: 9668efc2-7a0c-49e3-ae4b-af7b764fc7ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebar®
• Version Model Number: Rebar®
• Catalog Number: SCC-001-011
• Company DUNS: 140801007
• Company Name: ATLAS 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: 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 Dimensions

• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter
• Height: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M681SCC0010111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081880

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

[M681SCC0010111]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-01

On-Brand Devices [Rebar®]

• M681SCC0020140: 14mm Non-Lordotic Spacer
• M681SCC0020130: 13mm Non-Lordotic Spacer
• M681SCC0020120: 12mm Non-Lordotic Spacer
• M681SCC0020110: 11mm Non-Lordotic Spacer
• M681SCC0020100: 10mm Non-Lordotic Spacer
• M681SCC0020090: 9mm Non-Lordotic Spacer
• M681SCC0020080: 8mm Non-Lordotic Spacer
• M681SCC0020070: 7mm Non-Lordotic Spacer
• M681SCC0020060: 6mm Non-Lordotic Spacer
• M681SCC0020050: 5mm Non-Lordotic Spacer
• M681SCC0010140: 14mm Lordotic Spacer
• M681SCC0010130: 13mm Lordotic Spacer
• M681SCC0010120: 12mm Lordotic Spacer
• M681SCC0010111: 11mm Lordotic Spacer
• M681SCC0010100: 10mm Lordotic Spacer
• M681SCC0010090: 9mm Lordotic Spacer
• M681SCC0010080: 8mm Lordotic Spacer
• M681SCC0010070: 7mm Lordotic Spacer
• M681SCC0010060: 6mm Lordotic Spacer
• M681SCC0010050: 5mm Lordotic Spacer