Calcaneus Plate

GUDID B014FCM1

EMINENT SPINE LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: B014FCM1
• NIH Device Record Key: 87604ab8-4fc6-4136-8aed-6708b14f510e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcaneus Plate
• Version Model Number: FCM1
• 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	B014FCM1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143365

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

Moist Heat or Steam Sterilization

[B014FCM1]

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 [Calcaneus Plate]

• B014FCS2: FCS2
• B014FCS1: FCS1
• B014FCM2: FCM2
• B014FCM1: FCM1
• B014FCL2: FCL2
• B014FCL1: FCL1
• B014FC9: FC9
• B014FC3: FC3