FLS Plate, Square 21451-29

GUDID 09120047298817

FLS Plate, Square

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047298817
• NIH Device Record Key: 24d3916c-4ad3-49c2-8cc0-2e69e05298c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLS Plate, Square
• Version Model Number: 21451-29
• Catalog Number: 21451-29
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 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	09120047298817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131722

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

[09120047298817]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-08
• Device Publish Date: 2016-09-09

Devices Manufactured by I.T.S. GmbH

• 09120047301241 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=10mm, L=360mm
• 09120047301364 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=285mm
• 09120047301371 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=300mm
• 09120047301388 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=405mm
• 09120047301395 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=10mm, L=285mm
• 09120047301418 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=330mm
• 09120047301425 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=345mm
• 09120047301432 - Cannulated Tibia Nail: 2025-09-04 Cannulated Tibia Nail, D=9.0mm, L=360mm