Logical PX-Series

GUDID 09348215000462

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215000462
• NIH Device Record Key: 31550710-196d-4c48-8324-69e96aad5acd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical PX-Series
• Version Model Number: 111-12-2068
• 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	09348215000462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-09-28

On-Brand Devices [Logical PX-Series]

• 09348215000639: 111-12-2370
• 09348215000622: 111-12-2368
• 09348215000615: 111-12-2366
• 09348215000608: 111-12-2364
• 09348215000592: 111-12-2362
• 09348215000585: 111-12-2360
• 09348215000578: 111-12-2358
• 09348215000561: 111-12-2356
• 09348215000554: 111-12-2354
• 09348215000547: 111-12-2352
• 09348215000530: 111-12-2350
• 09348215000523: 111-12-2348
• 09348215000516: 111-12-2346
• 09348215000509: 111-12-2344
• 09348215000479: 111-12-2070
• 09348215000462: 111-12-2068
• 09348215000455: 111-12-2066
• 09348215000448: 111-12-2064
• 09348215000431: 111-12-2062
• 09348215000424: 111-12-2060
• 09348215000417: 111-12-2058
• 09348215000400: 111-12-2056
• 09348215000394: 111-12-2054
• 09348215000387: 111-12-2052
• 09348215000370: 111-12-2050
• 09348215000363: 111-12-2048
• 09348215000356: 111-12-2046
• 09348215000349: 111-12-2044