131-02-00

GUDID 10885862022493

LINER POSITIONER

Exactech, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10885862022493
• NIH Device Record Key: 46b3658e-dca4-4b49-afd1-db76f474a9c5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 131-02-00
• Catalog Number: 131-02-00
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862022493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173583

FDA Product Code

• OQI: Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

[10885862022493]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-05
• Device Publish Date: 2022-07-28

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