189-02-16

GUDID 10885862257529

BROACH, SIZE 16

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862257529
• NIH Device Record Key: 50c6146b-b76c-494f-b1c6-69e0f890edef
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 189-02-16
• Catalog Number: 189-02-16
• 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	10885862257529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140674

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

Moist Heat or Steam Sterilization

[10885862257529]

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

Devices Manufactured by Exactech, Inc.

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• 10885862250865 - Alteon: 2025-05-09
• 10885862250902 - Alteon: 2025-05-09
• 10885862594891 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 1
• 10885862594907 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 2
• 10885862594914 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 3
• 10885862594921 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 4
• 10885862594938 - Alteon: 2025-05-08 Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 5