Fine Osteotomy system - Distal femur

GUDID 00688346002195

Femoral plate, cortical compression screws

Laboratoires Bodycad Inc

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

• Primary Device ID: 00688346002195
• NIH Device Record Key: 21d518f1-d1f7-46c2-b991-da79618e35b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy system - Distal femur
• Version Model Number: 015-330-105
• 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: true
• 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	00688346002195 [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

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

Moist Heat or Steam Sterilization

[00688346002195]

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

On-Brand Devices [Fine Osteotomy system - Distal femur]

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• 00688346002102: Femoral Plate, Cancellous Compression Screws and Disposable Instrumentation
• 00688346002096: Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws and Disposable Instrumenta
• 00688346002089: Femoral Plate, Cortical Compression Screws, Cancellous Compression Screws and Disposable Instrum
• 00688346000313: Distal femur, plate, cortical screws compression, guides
• 00688346000306: Distal femur, plate, screws (cancellous compression, cortical compression, cortical locking), gu
• 00688346002218: Distal femur, plate, screws (cortical locking, cortical compression)
• 00688346002201: Femoral plate, cortical locking screws
• 00688346002195: Femoral plate, cortical compression screws
• 00688346002140: Femoral plate , Cortical Locking Screws, Cortical Compression Screws and disposable instrument
• 00688346002133: Femoral plate, cortical locking screws and disposable instrument
• 00688346000337: Distal femur, plate, screws (cortical locking, cortical compression), guides
• 00688346000320: Distal femur, plate, cortical locking screws, guides
• 00688346000290: Distal femur, plate, cancellous screws compression, guides
• 00688346000283: Distal femur, plate, screws (cortical locking, cancellous compression), guides
• 00688346000078: Distal femur, plate, screws (compression cortical/cancellous), guides