Spartan Stem Trial Neck

GUDID 09348215064358

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215064358
• NIH Device Record Key: ab3c5550-e27f-4f9a-b317-8fc39f548a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spartan Stem Trial Neck
• Version Model Number: 111-442-791
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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: true
• 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	09348215064358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192883

FDA Product Code

• HWT: Template

Sterilization

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

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

[09348215064358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [Spartan Stem Trial Neck]

• 09348215064396: 111-442-102
• 09348215064389: 111-442-101
• 09348215064372: 111-442-100
• 09348215064365: 111-442-792
• 09348215064358: 111-442-791
• 09348215064341: 111-442-790
• 09348215064334: 111-442-462
• 09348215064327: 111-442-461
• 09348215064310: 111-442-460
• 09348215064303: 111-442-132
• 09348215064297: 111-442-131
• 09348215064280: 111-442-130