201-41-03

GUDID 10885862042705

INTRA-MEDULLARY ROD, 3°, JOHANSON

Exactech, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10885862042705
• NIH Device Record Key: dee66150-eaf3-41fb-a3ed-7a920dcb67f7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 201-41-03
• Catalog Number: 201-41-03
• 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: 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 Dimensions

• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree
• Angle: 3 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862042705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011976

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

[10885862042705]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-06
• Device Publish Date: 2022-08-29

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