Remedy Hip Stem

GUDID 09348215053109

SIGNATURE ORTHOPAEDICS PTY LTD

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• Primary Device ID: 09348215053109
• NIH Device Record Key: e359bbcd-19b8-4851-a9a3-6778c9990fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remedy Hip Stem
• Version Model Number: D111-19-0200
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	09348215053109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Remedy Hip Stem]

• 09348215053338: D111-19-1201
• 09348215053321: D111-19-1101
• 09348215053314: D111-19-1001
• 09348215053307: D111-19-0901
• 09348215053291: D111-19-0801
• 09348215053284: D111-19-0701
• 09348215053277: D111-19-0601
• 09348215053260: D111-19-0501
• 09348215053253: D111-19-0401
• 09348215053246: D111-19-0301
• 09348215053239: D111-19-0201
• 09348215053222: D111-19-0101
• 09348215053215: D111-19-0001
• 09348215053208: D111-19-1200
• 09348215053192: D111-19-1100
• 09348215053185: D111-19-1000
• 09348215053178: D111-19-0900
• 09348215053161: D111-19-0800
• 09348215053154: D111-19-0700
• 09348215053147: D111-19-0600
• 09348215053130: D111-19-0500
• 09348215053123: D111-19-0400
• 09348215053116: D111-19-0300
• 09348215053109: D111-19-0200
• 09348215053093: D111-19-0100
• 09348215053086: D111-19-0000