Osteolock 5260-5-014

GUDID 07613327035636

3.5mm Hex Drive Head Cancellous Screw

Howmedica Osteonics Corp.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 07613327035636
• NIH Device Record Key: 955d0a64-ecf5-4a31-856e-71530a76eddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteolock
• Version Model Number: 5260-5-014
• Catalog Number: 5260-5-014
• 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

• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0
• Length: 14 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327035636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903362

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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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• 07613327035728: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035711: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035704: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035698: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035681: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035674: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035667: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035650: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035643: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035636: 3.5mm Hex Drive Head Cancellous Screw
• 07613327035629: 3.5mm Hex Drive Head Cancellous Screw