213-50-02

GUDID 10885862058652

STANDARD FINISHING GUIDE, SIZE 2

Exactech, Inc.

Osteotomy guide, reusable

• Primary Device ID: 10885862058652
• NIH Device Record Key: fceadbf5-ae0e-4112-a5a1-07a96b067fad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 213-50-02
• Catalog Number: 213-50-02
• 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: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862058652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032606

FDA Product Code

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

Sterilization

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

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

[10885862058652]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

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• 10885862648044 - Equinoxe: 2026-03-27 Trial, Resurfacing Head
• 10885862648051 - Equinoxe: 2026-03-27 Trial, Resurfacing Head
• 10885862648068 - Equinoxe: 2026-03-27 Trial, Resurfacing Head
• 10885862648075 - Equinoxe: 2026-03-27 Trial, Resurfacing Head
• 10885862648082 - Equinoxe: 2026-03-27 Trial, Resurfacing Head