Fine Osteotomy system - Proximal tibia 015-410-006

GUDID 00688346002300

Tibial plate cortical locking screws and disposable instrumentation

Laboratoires Bodycad Inc

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

• Primary Device ID: 00688346002300
• NIH Device Record Key: d9284de0-1b4e-47b5-a50a-4a462b05825b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy system - Proximal tibia
• Version Model Number: 015-410-006
• Catalog Number: 015-410-006
• 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: 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	00688346002300 [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

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

[00688346002300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-08
• Device Publish Date: 2021-11-30

On-Brand Devices [Fine Osteotomy system - Proximal tibia]

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• 00688346000443: Proximal tibia, plate cortical locking screws, guides
• 00688346000436: Proximal tibia, plate, cortical compression screws, guides
• 00688346000429: Proximal tibia, plate, screws (cancellous/ cortical compression, cortical locking), guides
• 00688346000412: Proximal tibia, plate, cancellous screws compression, guides
• 00688346000405: Proximal tibia, plate, screws (cortical locking, cancellous compression), guides
• 00688346000047: Proximal tibia, plate, screws (compression cortical/cancellous), guides