Fine Osteotomy disposable instruments - Proximal tibia 015-410-602

GUDID 00688346000542

Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, validators)

Laboratoires Bodycad Inc

Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00688346000542
• NIH Device Record Key: 9e2dc9a9-0a86-418c-ab96-7adf7f614b2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fine Osteotomy disposable instruments - Proximal tibia
• Version Model Number: 015-410-602
• Catalog Number: 015-410-602
• 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	00688346000542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193614

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

[00688346000542]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-05-20

On-Brand Devices [Fine Osteotomy disposable instruments - Proximal tibia]

• 00688346000559: Proximal tibia, disposable instruments (cutting guides, screws, drilling tower)
• 00688346000542: Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, validators)
• 00688346000139: Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide,
• 00688346002416: Cutting guides, drilling towers and retaining screws
• 00688346002409: Cutting guides, drilling tower, Open validators and retaining screws
• 00688346002393: Cutting guides, drilling towers, pre-drill guide, open validators and retaining screws