140-36-93

GUDID 10885862025586

Exactech, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 10885862025586
• NIH Device Record Key: c397c34b-ca11-4ba4-adc2-343474b064ef
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-36-93
• Catalog Number: 140-36-93
• 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

• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862025586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051682

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: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2017-06-27

Devices Manufactured by Exactech, Inc.

• 10885862653260 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 1
• 10885862653277 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 2
• 10885862653284 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 3
• 10885862653291 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 4
• 10885862653307 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 5
• 10885862653321 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 1.5
• 10885862653338 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 2.5
• 10885862653345 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 3.5