140-32-03

GUDID 10885862025456

Exactech, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 10885862025456
• NIH Device Record Key: 91acc815-c194-4ca9-9e0a-690b3baeef7b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-32-03
• Catalog Number: 140-32-03
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	10885862025456 [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.

• 10885862635105 - Truliant: 2024-08-12 Special Low Profile Truliant Tibial Resection Block, 3 Degree Posterior Slope, Left
• 10885862635112 - Truliant: 2024-08-12 Special Low Profile Truliant Tibial Resection Block, 3 Degree Posterior Slope, Right
• 10885862635129 - Truliant: 2024-08-12 Special Low Profile Truliant Tibial Resection Block, Left
• 10885862635136 - Truliant: 2024-08-12 Special Low Profile Truliant Tibial Resection Block, Right
• 10885862634108 - Equinoxe: 2024-07-16 Special Truliant Spike EM Tibial Guide
• 10885862634115 - Equinoxe: 2024-07-16 Special Spiked Tibial Resector Extractor Hook
• 10885862635044 - Equinoxe: 2024-07-16 Special Small Spiked Humeral Resection Cover
• 10885862635051 - Equinoxe: 2024-07-16 Special Medium Spiked Humeral Resection Cover