213-63-23

GUDID 10885862059802

AXIAL PATELLA REAMER 23MM INSET BLADE

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 10885862059802
• NIH Device Record Key: 7999552d-50d9-4c98-9668-e266cf81d789
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 213-63-23
• Catalog Number: 213-63-23
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter
• Width: 23 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862059802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933610

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

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• 10885862622730 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622747 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia
• 10885862622761 - Vantage: 2024-09-05 FIXED BEARING TIBIAL PLATE, 3D Tibia