PHYSICA PS 6535.54.811

GUDID 08033390212298

PHYSICA PS - Tibial Liner #8 H. 11 mm - LimaVit

LIMACORPORATE SPA

Tibial insert

• Primary Device ID: 08033390212298
• NIH Device Record Key: c42784e1-12c3-4b78-b687-5bb8bacdedc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA PS
• Version Model Number: 6535.54.811
• Catalog Number: 6535.54.811
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390212298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213381

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: 2022-02-11
• Device Publish Date: 2022-02-03

On-Brand Devices [PHYSICA PS]

• 08033390095686: PS Femoral Component Left #10
• 08033390095679: PS Femoral Component Left #9
• 08033390095662: PS Femoral Component Left #8
• 08033390095655: PS Femoral Component Left #7
• 08033390095648: PS Femoral Component Left #6
• 08033390095631: PS Femoral Component Left #5
• 08033390095624: PS Femoral Component Left #4
• 08033390095617: PS Femoral Component Left #3
• 08033390095600: PS Femoral Component Left #2
• 08033390095594: PS Femoral Component Left #1
• 08033390095587: PS Femoral components Right #10
• 08033390095570: PS Femoral components Right #9
• 08033390095563: PS Femoral components Right #8
• 08033390095556: PS Femoral components Right #7
• 08033390095549: PS Femoral components Right #6
• 08033390095532: PS Femoral components Right #5
• 08033390095525: PS Femoral components Right #4
• 08033390095518: PS Femoral components Right #3
• 08033390095501: PS Femoral components Right #2
• 08033390095495: PS Femoral components Right #1
• 08033390100021: Pegs for PS femoral components
• 08033390212458: PHYSICA PS - Tibial Liner #10 H. 20 mm - LimaVit
• 08033390212441: PHYSICA PS - Tibial Liner #10 H. 16 mm - LimaVit
• 08033390212434: PHYSICA PS - Tibial Liner #10 H. 14 mm - LimaVit
• 08033390212427: PHYSICA PS - Tibial Liner #10 H. 12 mm - LimaVit
• 08033390212410: PHYSICA PS - Tibial Liner #10 H. 11 mm - LimaVit
• 08033390212403: PHYSICA PS - Tibial Liner #10 H. 10 mm - LimaVit
• 08033390212397: PHYSICA PS - Tibial Liner #9 H. 20 mm - LimaVit
• 08033390212380: PHYSICA PS - Tibial Liner #9 H. 16 mm - LimaVit
• 08033390212373: PHYSICA PS - Tibial Liner #9 H. 14 mm - LimaVit
• 08033390212366: PHYSICA PS - Tibial Liner #9 H. 12 mm - LimaVit
• 08033390212359: PHYSICA PS - Tibial Liner #9 H. 11 mm - LimaVit
• 08033390212342: PHYSICA PS - Tibial Liner #9 H. 10 mm - LimaVit
• 08033390212335: PHYSICA PS - Tibial Liner #8 H. 20 mm - LimaVit
• 08033390212328: PHYSICA PS - Tibial Liner #8 H. 16 mm - LimaVit
• 08033390212311: PHYSICA PS - Tibial Liner #8 H. 14 mm - LimaVit
• 08033390212304: PHYSICA PS - Tibial Liner #8 H. 12 mm - LimaVit
• 08033390212298: PHYSICA PS - Tibial Liner #8 H. 11 mm - LimaVit
• 08033390212281: PHYSICA PS - Tibial Liner #8 H. 10 mm - LimaVit
• 08033390212274: PHYSICA PS - Tibial Liner #7 H. 20 mm - LimaVit
• 08033390212267: PHYSICA PS - Tibial Liner #7 H. 16 mm - LimaVit
• 08033390212250: PHYSICA PS - Tibial Liner #7 H. 14 mm - LimaVit
• 08033390212243: PHYSICA PS - Tibial Liner #7 H. 12 mm - LimaVit
• 08033390212236: PHYSICA PS - Tibial Liner #7 H. 11 mm - LimaVit
• 08033390212212: PHYSICA PS - Tibial Liner #6 H. 20 mm - LimaVit
• 08033390212205: PHYSICA PS - Tibial Liner #6 H. 16 mm - LimaVit
• 08033390212199: PHYSICA PS - Tibial Liner #6 H. 14 mm - LimaVit
• 08033390212182: PHYSICA PS - Tibial Liner #6 H. 12 mm - LimaVit
• 08033390212175: PHYSICA PS - Tibial Liner #6 H. 11 mm - LimaVit
• 08033390212168: PHYSICA PS - Tibial Liner #6 H. 10 mm - LimaVit