Sleeve 17-0000E

GUDID 07613327016468

Use Only with V40 Taper Stems

Howmedica Osteonics Corp.

Femoral head/stem prosthesis adaptor

• Primary Device ID: 07613327016468
• NIH Device Record Key: 6e43daaa-4be4-464b-9584-142b5ec66fbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleeve
• Version Model Number: 17-0000E
• Catalog Number: 17-0000E
• 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	07613327016468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003379

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

Devices Manufactured by Howmedica Osteonics Corp.

• 07613327564815 - INSTRUMENT: 2024-03-21 Exeter X3 RimFit Cups Template (7309)
• 07613327565874 - INSTRUMENT: 2024-03-21 Restoration Modular Revision Hip System - Conical Distal Stem (Straight) 115mm Template
• 07613327404876 - INSTRUMENT: 2023-11-10 Triathlon Pro Femoral Trial
• 07613327404883 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Anterior Bushing
• 07613327404890 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Anterior Bushing
• 07613327404906 - INSTRUMENT: 2023-11-10 Triathlon Pro Modular PS Box Trial
• 07613327404913 - INSTRUMENT: 2023-11-10 Triathlon Pro PS Box Cut Protector
• 07613327404920 - INSTRUMENT: 2023-11-10 Triathlon Pro Modular PS Box Trial