Spartan Stem Broach

GUDID 09348215064402

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215064402
• NIH Device Record Key: 54e2ddd9-1542-4163-89ef-fbc516b07012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spartan Stem Broach
• Version Model Number: 111-44-2001
• 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	09348215064402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192883

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

[09348215064402]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-11
• Device Publish Date: 2022-02-03

On-Brand Devices [Spartan Stem Broach]

• 09348215064518: 111-44-2012
• 09348215064501: 111-44-2011
• 09348215064495: 111-44-2010
• 09348215064488: 111-44-2009
• 09348215064471: 111-44-2008
• 09348215064464: 111-44-2007
• 09348215064457: 111-44-2006
• 09348215064440: 111-44-2005
• 09348215064433: 111-44-2004
• 09348215064426: 111-44-2003
• 09348215064419: 111-44-2002
• 09348215064402: 111-44-2001