Rattlesnake

GUDID B014RS8512

EMINENT SPINE LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B014RS8512
• NIH Device Record Key: b9a6484b-67a6-47cf-873d-b732fcab66dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rattlesnake
• Version Model Number: RS8512
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B014RS8512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[B014RS8512]

Moist Heat or Steam Sterilization

[B014RS8512]

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: 2017-02-09

On-Brand Devices [Rattlesnake]

• B014RS8616: RS8616
• B014RS8614: RS8614
• B014RS8612: RS8612
• B014RS8610: RS8610
• B014RS8516: RS8516
• B014RS8514: RS8514
• B014RS8512: RS8512
• B014RS8510: RS8510
• B014RS8508: RS8508
• B014RS8116: RS8116
• B014RS8114: RS8114
• B014RS8112: RS8112
• B014RS8110: RS8110
• B014RS8016: RS8016
• B014RS8014: RS8014
• B014RS8012: RS8012
• B014RS8010: RS8010
• B014RS8008: RS8008
• B014RS7616: RS7616
• B014RS7614: RS7614
• B014RS7612: RS7612
• B014RS7610: RS7610
• B014RS7516: RS7516
• B014RS7514: RS7514
• B014RS7512: RS7512
• B014RS7510: RS7510
• B014RS7508: RS7508
• B014RS7216: RS7216
• B014RS7214: RS7214
• B014RS7212: RS7212
• B014RS7210: RS7210
• B014RS7208: RS7208
• B014RS7116: RS7116
• B014RS7114: RS7114
• B014RS7112: RS7112
• B014RS7110: RS7110
• B014RS7016: RS7016
• B014RS7014: RS7014
• B014RS7012: RS7012
• B014RS7010: RS7010
• B014RS7008: RS7008
• B014RS6616: RS6616
• B014RS6614: RS6614
• B014RS6612: RS6612
• B014RS6610: RS6610
• B014RS6516: RS6516
• B014RS6514: RS6514
• B014RS6512: RS6512
• B014RS6510: RS6510
• B014RS6508: RS6508