RISE

GUDID 00889095213478

RISE Spacer 8x22mm, 9-15mm, 15°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095213478
• NIH Device Record Key: e012772a-f957-45d4-b292-9577ec0e12fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RISE
• Version Model Number: 193.031
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095213478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113447

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889095213478]

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: 2015-11-07

On-Brand Devices [RISE]

• 00889095214253: RISE-L Spacer 22 x 60mm, 10-17mm, 10deg
• 00889095214246: RISE-L Spacer 22 x 55mm, 10-17mm, 10deg
• 00889095214239: RISE-L Spacer 22 x 50mm, 10-17mm, 10deg
• 00889095214222: RISE-L Spacer 22 x 45mm, 10-17mm, 10deg
• 00889095214215: RISE-L Spacer 22 x 40mm, 10-17mm, 10deg
• 00889095214185: RISE-L Spacer 22 x 60mm, 8-15mm, 6deg
• 00889095214178: RISE-L Spacer 22 x 55mm, 8-15mm, 6deg
• 00889095214161: RISE-L Spacer 22 x 50mm, 8-15mm, 6deg
• 00889095214154: RISE-L Spacer 22 x 45mm, 8-15mm, 6deg
• 00889095214147: RISE-L Spacer 22 x 40mm, 8-15mm, 6deg
• 00889095214116: RISE-L Spacer 22 x 60mm, 10-17mm
• 00889095214109: RISE-L Spacer 22 x 55mm, 10-17mm
• 00889095214093: RISE-L Spacer 22 x 50mm, 10-17mm
• 00889095214086: RISE-L Spacer 22 x 45mm, 10-17mm
• 00889095214079: RISE-L Spacer 22 x 40mm, 10-17mm
• 00889095214048: RISE-L Spacer 22 x 60mm, 7-14mm
• 00889095214031: RISE-L Spacer 22 x 55mm, 7-14mm
• 00889095214024: RISE-L Spacer 22 x 50mm, 7-14mm
• 00889095214017: RISE-L Spacer 22 x 45mm, 7-14mm
• 00889095214000: RISE-L Spacer 22 x 40mm, 7-14mm
• 00889095213973: RISE-L Spacer 18 x 60mm, 10-17mm, 10deg
• 00889095213966: RISE-L Spacer 18 x 55mm, 10-17mm, 10deg
• 00889095213959: RISE-L Spacer 18 x 50mm, 10-17mm, 10deg
• 00889095213942: RISE-L Spacer 18 x 45mm, 10-17mm, 10deg
• 00889095213935: RISE-L Spacer 18 x 40mm, 10-17mm, 10deg
• 00889095213904: RISE-L Spacer 18 x 60mm, 8-15mm, 6deg
• 00889095213898: RISE-L Spacer 18 x 55mm, 8-15mm, 6deg
• 00889095213881: RISE-L Spacer 18 x 50mm, 8-15mm, 6deg
• 00889095213874: RISE-L Spacer 18 x 45mm, 8-15mm, 6deg
• 00889095213867: RISE-L Spacer 18 x 40mm, 8-15mm, 6deg
• 00889095213836: RISE-L Spacer 18 x 60mm, 10-17mm
• 00889095213829: RISE-L Spacer 18 x 55mm, 10-17mm
• 00889095213812: RISE-L Spacer 18 x 50mm, 10-17mm
• 00889095213805: RISE-L Spacer 18 x 45mm, 10-17mm
• 00889095213799: RISE-L Spacer 18 x 40mm, 10-17mm
• 00889095213768: RISE-L Spacer 18 x 60mm, 7-14mm
• 00889095213751: RISE-L Spacer 18 x 55mm, 7-14mm
• 00889095213744: RISE-L Spacer 18 x 50mm, 7-14mm
• 00889095213737: RISE-L Spacer 18 x 45mm, 7-14mm
• 00889095213720: RISE-L Spacer 18 x 40mm, 7-14mm
• 00889095213706: RISE Spacer 12x30mm, 10-17mm, 15°
• 00889095213690: RISE Spacer 12x26mm, 10-17mm, 15°
• 00889095213683: RISE Spacer 12x30mm, 8-15mm, 10°
• 00889095213676: RISE Spacer 12x26mm, 8-15mm, 10°
• 00889095213669: RISE Spacer 12x30mm, 10-17mm
• 00889095213652: RISE Spacer 12x26mm, 10-17mm
• 00889095213645: RISE Spacer 12x30mm, 7-14mm
• 00889095213638: RISE Spacer 12x26mm, 7-14mm
• 00889095213621: RISE Spacer 10x22mm, 9-15mm
• 00889095213614: RISE Spacer 10x30mm, 10-17mm, 15°