113-01-05

GUDID 10885862016744

BROACH, PRIMARY, SIZE 5

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862016744
• NIH Device Record Key: e15a0b37-08ee-4f22-8cca-4c7d053c23ec
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 113-01-05
• Catalog Number: 113-01-05
• 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	10885862016744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041906

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

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

Moist Heat or Steam Sterilization

[10885862016744]

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.

• 10885862658159 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +0, 12/14
• 10885862658166 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +3, 12/14
• 10885862658173 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +7, 12/14
• 10885862658180 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +10, 12/14
• 10885862658197 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +0, 12/14
• 10885862658203 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +3.5, 12/14
• 10885862658210 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +7, 12/14
• 10885862658227 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 28mm O.D., +10, 12/14