Swivel Stem Impactor

GUDID 09348215137427

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic implant impactor, reusable

• Primary Device ID: 09348215137427
• NIH Device Record Key: 130aa915-a127-42b8-a6dc-19bad893f0e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swivel Stem Impactor
• Version Model Number: 112-32-0313
• 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: 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	09348215137427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243021

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

[09348215137427]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-09
• Device Publish Date: 2025-10-10

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215039295 - Liner Impactor: 2026-02-09
• 09348215039301 - Liner Impactor: 2026-02-09
• 09348215039318 - Liner Impactor: 2026-02-09
• 09348215039325 - Liner Impactor: 2026-02-09
• 09348215039332 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039349 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039356 - Ceramic Liner Inserter Impactor Head: 2026-02-09
• 09348215039363 - Ceramic Liner Inserter Impactor Head: 2026-02-09