207-47-00

GUDID 10885862053022

TENSOR, LBS

Exactech, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10885862053022
• NIH Device Record Key: 6693e579-b53f-4c4e-89b8-cfb8b07a07bd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 207-47-00
• Catalog Number: 207-47-00
• 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	10885862053022 [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

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

Moist Heat or Steam Sterilization

[10885862053022]

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.

• 10885862633361 - Equinoxe: 2025-05-23 Special Extended Klimo Inserter
• 10885862650474 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 36MM, +0
• 10885862650481 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 36MM, +2.5
• 10885862650498 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 38MM, +0
• 10885862650504 - Equinoxe: 2025-05-23 SPECIAL HUMERAL TRAY TRIAL, 38MM, +2.5
• 10885862653246 - Novation: 2025-05-23 Special Novation Broach Handle
• 10885862656186 - Truliant: 2025-05-23 Special EM Tibial Resector, Upper Assembly
• 10885862657107 - Vantage: 2025-05-20 3D Tibial Cut Block - Size 1