Texas Diamondback

GUDID B014DBCM5550

EMINENT SPINE LLC

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

• Primary Device ID: B014DBCM5550
• NIH Device Record Key: 96575483-65a8-4ae1-a2f7-24f913f00a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Texas Diamondback
• Version Model Number: DBCM5550
• 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	B014DBCM5550 [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

[B014DBCM5550]

Moist Heat or Steam Sterilization

[B014DBCM5550]

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: 2017-02-13

On-Brand Devices [Texas Diamondback]

• B014DBCM7560: DBCM7560
• B014DBCM7555: DBCM7555
• B014DBCM7550: DBCM7550
• B014DBCM7545: DBCM7545
• B014DBCM7540: DBCM7540
• B014DBCM7535: DBCM7535
• B014DBCM7530: DBCM7530
• B014DBCM6555: DBCM6555
• B014DBCM6550: DBCM6550
• B014DBCM6545: DBCM6545
• B014DBCM6540: DBCM6540
• B014DBCM6535: DBCM6535
• B014DBCM6530: DBCM6530
• B014DBCM5555: DBCM5555
• B014DBCM5550: DBCM5550
• B014DBCM5545: DBCM5545
• B014DBCM5540: DBCM5540
• B014DBCM5535: DBCM5535
• B014DBCM5530: DBCM5530
• B014DBCM5525: DBCM5525
• B014DB5120: DB5120
• B014DB5110: DB5110
• B014DB5100: DB5100
• B014DB5095: DB5095
• B014DB5090: DB5090
• B014DB5085: DB5085
• B014DB5080: DB5080
• B014DB5075: DB5075
• B014DB5070: DB5070
• B014DB5065: DB5065
• B014DB5060: DB5060
• B014DB5055: DB5055
• B014DB5050: DB5050
• B014DB5045: DB5045
• B014DB5040: DB5040
• B014DB4120: DB4120
• B014DB4100: DB4100
• B014DB4095: DB4095
• B014DB4090: DB4090
• B014DB4085: DB4085
• B014DB4080: DB4080
• B014DB4075: DB4075
• B014DB4070: DB4070
• B014DB4065: DB4065
• B014DB4060: DB4060
• B014DB4055: DB4055
• B014DB4050: DB4050
• B014DB4045: DB4045
• B014DB4040: DB4040