Fine Osteotomy system - Distal femur 015-330-006

GUDID 00688346002133

Femoral plate, cortical locking screws and disposable instrument

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00688346002133
• NIH Device Record Key: 4e1925c9-e760-4c8f-9864-3365d71785d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy system - Distal femur
• Version Model Number: 015-330-006
• Catalog Number: 015-330-006
• Company DUNS: 202981171
• Company Name: Laboratoires Bodycad 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: false
• Serial Number: true
• 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
GS1	00688346002133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211646

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

[00688346002133]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-07
• Device Publish Date: 2021-11-29

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• 00688346002089: Femoral Plate, Cortical Compression Screws, Cancellous Compression Screws and Disposable Instrum
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• 00688346000320: Distal femur, plate, cortical locking screws, guides
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• 00688346000078: Distal femur, plate, screws (compression cortical/cancellous), guides