Diamondback

GUDID B014DB1095

EMINENT SPINE LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B014DB1095
• NIH Device Record Key: 9396ceff-5889-433b-a1d7-a538fd8bf34b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamondback
• Version Model Number: DB1095
• 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	B014DB1095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100377

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[B014DB1095]

Moist Heat or Steam Sterilization

[B014DB1095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-29
• Device Publish Date: 2017-02-08

On-Brand Devices [Diamondback]

• B014DBRR7560: DBRR7560
• B014DBRR7555: DBRR7555
• B014DBRR7550: DBRR7550
• B014DBRR7545: DBRR7545
• B014DBRR7540: DBRR7540
• B014DBRR7535: DBRR7535
• B014DBRR7530: DBRR7530
• B014DBRR6555: DBRR6555
• B014DBRR6550: DBRR6550
• B014DBRR6545: DBRR6545
• B014DBRR6540: DBRR6540
• B014DBRR6535: DBRR6535
• B014DBRR6530: DBRR6530
• B014DBRR5555: DBRR5555
• B014DBRR5550: DBRR5550
• B014DBRR5545: DBRR5545
• B014DBRR5540: DBRR5540
• B014DBRR5535: DBRR5535
• B014DBRR5530: DBRR5530
• B014DBRR5525: DBRR5525
• B014DBRR5040: DBRR5040
• B014DBRR5035: DBRR5035
• B014DBRR5030: DBRR5030
• B014DBRR5025: DBRR5025
• B014DBRR4550: DBRR4550
• B014DBRR4545: DBRR4545
• B014DBRR4540: DBRR4540
• B014DBRR4535: DBRR4535
• B014DBRR4530: DBRR4530
• B014DBRR4525: DBRR4525
• B014DBR7560: DBR7560
• B014DBR7555: DBR7555
• B014DBR7550: DBR7550
• B014DBR7545: DBR7545
• B014DBR7540: DBR7540
• B014DBR7535: DBR7535
• B014DBR7530: DBR7530
• B014DBR6555: DBR6555
• B014DBR6550: DBR6550
• B014DBR6545: DBR6545
• B014DBR6540: DBR6540
• B014DBR6535: DBR6535
• B014DBR6530: DBR6530
• B014DBR5555: DBR5555
• B014DBR5550: DBR5550
• B014DBR5545: DBR5545
• B014DBR5540: DBR5540
• B014DBR5535: DBR5535
• B014DBR5530: DBR5530
• B014DBR5525: DBR5525