Biolox 6519-1-040

GUDID 04546540608444

Anatomic Universal Taper Femoral Head

Howmedica Osteonics Corp.

Femoral head/stem prosthesis adaptor

• Primary Device ID: 04546540608444
• NIH Device Record Key: d6aee1d3-d71b-49df-9e64-be830e30cd27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox
• Version Model Number: 6519-1-040
• Catalog Number: 6519-1-040
• 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: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter
• Outer Diameter: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540608444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070885

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

On-Brand Devices [Biolox]

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• 07613154187324: Ceramic C-Taper Femoral Head
• 07613154187317: Ceramic C-Taper Femoral Head
• 07613154187300: Ceramic C-Taper Femoral Head
• 07613154187294: Ceramic C-Taper Femoral Head
• 07613154187287: Ceramic C-Taper Femoral Head
• 07613154187270: Ceramic C-Taper Femoral Head
• 07613154187263: Ceramic C-Taper Femoral Head
• 07613154187256: Ceramic C-Taper Femoral Head
• 07613154166541: Ceramic C-Taper Femoral Head
• 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
• 04546540608512: Ceramic V40 Femoral Head
• 04546540608505: Ceramic V40 Femoral Head
• 04546540608499: Ceramic V40 Femoral Head
• 04546540608482: Ceramic V40 Femoral Head
• 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
• 04546540608307: Ceramic C-Taper Femoral Head
• 04546540608291: Ceramic C-Taper Femoral Head
• 07613327602722: Ceramic V40 Femoral Head
• 07613327602715: Ceramic V40 Femoral Head