Rx Knee All Poly Tibia Augment - 3deg Wedge

GUDID 09348215111892

SIGNATURE ORTHOPAEDICS PTY LTD

Temporary knee prosthesis, non-customized

• Primary Device ID: 09348215111892
• NIH Device Record Key: 7412e49e-a044-4ede-9a48-5cb98827f6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rx Knee All Poly Tibia Augment - 3deg Wedge
• Version Model Number: 121-20-9309
• 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	09348215111892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240683

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Rx Knee All Poly Tibia Augment - 3deg Wedge]

• 09348215124168: 121-20-9229
• 09348215124151: 121-20-9228
• 09348215124144: 121-20-9227
• 09348215124137: 121-20-9226
• 09348215124120: 121-20-9225
• 09348215124113: 121-20-9224
• 09348215124106: 121-20-9223
• 09348215124090: 121-20-9222
• 09348215124083: 121-20-9221
• 09348215124076: 121-20-9319
• 09348215124069: 121-20-9318
• 09348215124052: 121-20-9317
• 09348215124045: 121-20-9316
• 09348215124038: 121-20-9315
• 09348215124021: 121-20-9314
• 09348215124014: 121-20-9313
• 09348215124007: 121-20-9312
• 09348215123994: 121-20-9311
• 09348215111892: 121-20-9309
• 09348215111885: 121-20-9308
• 09348215111878: 121-20-9307
• 09348215111861: 121-20-9306
• 09348215111854: 121-20-9305
• 09348215111847: 121-20-9304
• 09348215111830: 121-20-9303
• 09348215111823: 121-20-9302
• 09348215111816: 121-20-9301
• 09348215110864: 121-20-9239
• 09348215110857: 121-20-9238
• 09348215110840: 121-20-9237
• 09348215110833: 121-20-9236
• 09348215110826: 121-20-9235
• 09348215110819: 121-20-9234
• 09348215110802: 121-20-9233
• 09348215110796: 121-20-9232
• 09348215110789: 121-20-9231