140-32-93

GUDID 10885862025494

Exactech, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 10885862025494
• NIH Device Record Key: f7676ad8-76c0-4f9c-adf8-f94411e347b7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-32-93
• Catalog Number: 140-32-93
• 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

• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 32 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862025494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032964

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2014-09-01

Devices Manufactured by Exactech, Inc.

• 10885862633361 - Equinoxe: 2025-05-23 Special Extended Klimo Inserter
• 10885862650474 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 36MM, +0
• 10885862650481 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 36MM, +2.5
• 10885862650498 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 38MM, +0
• 10885862650504 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 38MM, +2.5
• 10885862653246 - Novation: 2025-05-23 Special Novation Broach Handle
• 10885862656186 - Truliant: 2025-05-23 Special EM Tibial Resector, Upper Assembly
• 10885862657107 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 1