Plug 5260-4-000

GUDID 07613327036602

Osteolock Apical Plug

Howmedica Osteonics Corp.

Acetabulum prosthesis hole plug

• Primary Device ID: 07613327036602
• NIH Device Record Key: ef0f9193-7dc6-4242-9582-acd8421b7a44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plug
• Version Model Number: 5260-4-000
• Catalog Number: 5260-4-000
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327036602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971854

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 [Plug]

• 07613327036602: Osteolock Apical Plug
• 07613327013887: Distal Hole Plug