Biolox 6570-0-536

GUDID 04546540608574

Ceramic V40 Femoral Head

Howmedica Osteonics Corp.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 04546540608574
• NIH Device Record Key: 3c0fb743-5321-4bab-9beb-49972d3b95b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox
• Version Model Number: 6570-0-536
• Catalog Number: 6570-0-536
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: false
• 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 Dimensions

• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540608574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052718

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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• 07613154166534: Ceramic C-Taper Femoral Head
• 07613154166527: Ceramic C-Taper Femoral Head
• 04546540608581: Ceramic V40 Femoral Head
• 04546540608574: Ceramic V40 Femoral Head
• 04546540608567: Ceramic V40 Femoral Head
• 04546540608550: Ceramic V40 Femoral Head
• 04546540608543: Ceramic V40 Femoral Head
• 04546540608536: Ceramic V40 Femoral Head
• 04546540608529: Ceramic V40 Femoral Head
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• 04546540608475: Ceramic V40 Femoral Head
• 04546540608468: Ceramic V40 Femoral Head
• 04546540608451: Anatomic Universal Taper Femoral Head
• 04546540608444: Anatomic Universal Taper Femoral Head
• 04546540608437: Anatomic Universal Taper Femoral Head
• 04546540608420: Universal Taper Femoral Head
• 04546540608413: Universal Taper Femoral Head
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• 04546540608291: Ceramic C-Taper Femoral Head