Hallux Osteotomy Plate 21015-09

GUDID 09120034308543

Hallux Osteotomy Plate, 9mm

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034308543
• NIH Device Record Key: 330462f9-c792-4bbe-922e-01b32ddb4b05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hallux Osteotomy Plate
• Version Model Number: 21015-09
• Catalog Number: 21015-09
• 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	09120034308543 [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

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

Moist Heat or Steam Sterilization

[09120034308543]

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

On-Brand Devices [Hallux Osteotomy Plate]

• 09120047298749: Hallux Osteotomy Plate, 10mm
• 09120047298664: Hallux Osteotomy Plate, 8mm
• 09120034308543: Hallux Osteotomy Plate, 9mm