140-28-93

GUDID 10885862025432

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: 10885862025432
• NIH Device Record Key: dca5813e-6487-47c9-8ea1-d701443fae66
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 140-28-93
• Catalog Number: 140-28-93
• 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: 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	10885862025432 [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.

• 10885862634931 - Accumatch: 2024-05-10 Special 3.2 mm Drill Guide
• 10885862634948 - Accumatch: 2024-05-10 Special 4.5mm Drill Guide
• 10885862595447 - Equinoxe: 2024-04-22 PHx Humeral Plate Instrument Case, Base
• 10885862595454 - Equinoxe: 2024-04-22 PHx Humeral Plate Instrument Case, Tray
• 10885862595461 - Equinoxe: 2024-04-22 PHx Humeral Plate Compression Screw Caddy
• 10885862595478 - Equinoxe: 2024-04-22 PHx Humeral Plate Locking Screw Caddy
• 10885862595485 - Equinoxe: 2024-04-22 PHx Humeral Plate 6.5mm Screw Caddy
• 10885862628947 - EXACTECHGPS: 2024-04-15 Station V3