HEDRON

GUDID 00193982191566

HEDRON IA Spacer, 26x34, 19mm, 8°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00193982191566
• NIH Device Record Key: cd4a8f70-b8f9-479b-9884-fe9b8953d990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEDRON
• Version Model Number: 1212.0619S
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Height: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982191566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191391

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-12-27

On-Brand Devices [HEDRON]

• 00193982128616: HEDRON IC Spacer, 10.5x18, 12mm, 12°
• 00193982128609: HEDRON IC Spacer, 10.5x18, 11mm, 12°
• 00193982128593: HEDRON IC Spacer, 10.5x18, 10mm, 12°
• 00193982128586: HEDRON IC Spacer, 10.5x18, 9mm, 12°
• 00193982128579: HEDRON IC Spacer, 10.5x18, 8mm, 12°
• 00193982128562: HEDRON IC Spacer, 10.5x18, 7mm, 12°
• 00193982128555: HEDRON IC Spacer, 10.5x18, 6mm, 12°
• 00193982128548: HEDRON IC Spacer, 10.5x18, 5mm, 12°
• 00193982128531: HEDRON IC Spacer, 10.5x18, 12mm, 7°
• 00193982128524: HEDRON IC Spacer, 10.5x18, 11mm, 7°
• 00193982128517: HEDRON IC Spacer, 10.5x18, 10mm, 7°
• 00193982128500: HEDRON IC Spacer, 10.5x18, 9mm, 7°
• 00193982128494: HEDRON IC Spacer, 10.5x18, 8mm, 7°
• 00193982128487: HEDRON IC Spacer, 10.5x18, 7mm, 7°
• 00193982128470: HEDRON IC Spacer, 10.5x18, 6mm, 7°
• 00193982128463: HEDRON IC Spacer, 10.5x18, 5mm, 7°
• 00193982128234: HEDRON IC Spacer, 10.5x18, 12mm, 0°
• 00193982128227: HEDRON IC Spacer, 10.5x18, 11mm, 0°
• 00193982128210: HEDRON IC Spacer, 10.5x18, 10mm, 0°
• 00193982128203: HEDRON IC Spacer, 10.5x18, 9mm, 0°
• 00193982128197: HEDRON IC Spacer, 10.5x18, 8mm, 0°
• 00193982128180: HEDRON IC Spacer, 10.5x18, 7mm, 0°
• 00193982128173: HEDRON IC Spacer, 10.5x18, 6mm, 0°
• 00193982128166: HEDRON IC Spacer, 10.5x18, 5mm, 0°
• 00193982127336: HEDRON IC Spacer, 10x16, 12mm, 12°
• 00193982127329: HEDRON IC Spacer, 10x16, 11mm, 12°
• 00193982127312: HEDRON IC Spacer, 10x16, 10mm, 12°
• 00193982127305: HEDRON IC Spacer, 10x16, 9mm, 12°
• 00193982127299: HEDRON IC Spacer, 10x16, 8mm, 12°
• 00193982127282: HEDRON IC Spacer, 10x16, 7mm, 12°
• 00193982127275: HEDRON IC Spacer, 10x16, 6mm, 12°
• 00193982127268: HEDRON IC Spacer, 10x16, 5mm, 12°
• 00193982127251: HEDRON IC Spacer, 10x16, 12mm, 7°
• 00193982127244: HEDRON IC Spacer, 10x16, 11mm, 7°
• 00193982127237: HEDRON IC Spacer, 10x16, 10mm, 7°
• 00193982127220: HEDRON IC Spacer, 10x16, 9mm, 7°
• 00193982127213: HEDRON IC Spacer, 10x16, 8mm, 7°
• 00193982127206: HEDRON IC Spacer, 10x16, 7mm, 7°
• 00193982127190: HEDRON IC Spacer, 10x16, 6mm, 7°
• 00193982127183: HEDRON IC Spacer, 10x16, 5mm, 7°
• 00193982126957: HEDRON IC Spacer, 10x16, 12mm, 0°
• 00193982126940: HEDRON IC Spacer, 10x16, 11mm, 0°
• 00193982126933: HEDRON IC Spacer, 10x16, 10mm, 0°
• 00193982126926: HEDRON IC Spacer, 10x16, 9mm, 0°
• 00193982126919: HEDRON IC Spacer, 10x16, 8mm, 0°
• 00193982126902: HEDRON IC Spacer, 10x16, 7mm, 0°
• 00193982126896: HEDRON IC Spacer, 10x16, 6mm, 0°
• 00193982126889: HEDRON IC Spacer, 10x16, 5mm, 0°
• 00193982126018: HEDRON IC Spacer, 8x14, 12mm, 12°
• 00193982126001: HEDRON IC Spacer, 8x14, 11mm, 12°