140-28-00

GUDID 10885862025395

Exactech, Inc.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 10885862025395
• NIH Device Record Key: 22e1ba2d-08e2-4fc8-80cb-cc8fb9e9a44b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-28-00
• Catalog Number: 140-28-00
• 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: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862025395 [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.

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• 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
• 10885862635068 - Equinoxe: 2024-07-16 Special Large Spiked Humeral Resection Cover
• 10885862635143 - Equinoxe: 2024-07-16 Special Laser Cage Trephine Drill. 0-8 Deg, Peripheral Pegs
• 10885862635150 - Equinoxe: 2024-07-16 Special Laser Cage Trephone Drill. 0-8 Deg, Central Cage
• 10885862630704 - Equinoxe: 2024-06-20 Special Modular rTSA 32mm Circular Reamer