PHYSICA HPS 6539.54.A12

GUDID 08033390213042

PHYSICA HPS - Tibial Liner #10 H. 12 mm - LimaVit

LIMACORPORATE SPA

Tibial insert

• Primary Device ID: 08033390213042
• NIH Device Record Key: 9a2c26f1-e008-47a2-bd2a-596495f7db6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA HPS
• Version Model Number: 6539.54.A12
• Catalog Number: 6539.54.A12
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390213042 [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: 2022-02-14
• Device Publish Date: 2022-02-04

On-Brand Devices [PHYSICA HPS]

• 08033390213066: PHYSICA HPS - Tibial Liner #10 H. 16 mm - LimaVit
• 08033390213059: PHYSICA HPS - Tibial Liner #10 H. 14 mm - LimaVit
• 08033390213042: PHYSICA HPS - Tibial Liner #10 H. 12 mm - LimaVit
• 08033390213035: PHYSICA HPS - Tibial Liner #10 H. 11 mm - LimaVit
• 08033390213028: PHYSICA HPS - Tibial Liner #10 H. 10 mm - LimaVit
• 08033390213011: PHYSICA HPS - Tibial Liner #9 H. 20 mm - LimaVit
• 08033390213004: PHYSICA HPS - Tibial Liner #9 H. 16 mm - LimaVit
• 08033390212991: PHYSICA HPS - Tibial Liner #9 H. 14 mm - LimaVit
• 08033390212984: PHYSICA HPS - Tibial Liner #9 H. 12 mm - LimaVit
• 08033390212977: PHYSICA HPS - Tibial Liner #9 H. 11 mm - LimaVit
• 08033390212960: PHYSICA HPS - Tibial Liner #9 H. 10 mm - LimaVit
• 08033390212953: PHYSICA HPS - Tibial Liner #8 H. 20 mm - LimaVit
• 08033390212946: PHYSICA HPS - Tibial Liner #8 H. 16 mm - LimaVit
• 08033390212939: PHYSICA HPS - Tibial Liner #8 H. 14 mm - LimaVit
• 08033390212922: PHYSICA HPS - Tibial Liner #8 H. 12 mm - LimaVit
• 08033390212915: PHYSICA HPS - Tibial Liner #8 H. 11 mm - LimaVit
• 08033390212908: PHYSICA HPS - Tibial Liner #8 H. 10 mm - LimaVit
• 08033390212892: PHYSICA HPS - Tibial Liner #7 H. 20 mm - LimaVit
• 08033390212885: PHYSICA HPS - Tibial Liner #7 H. 16 mm - LimaVit
• 08033390212878: PHYSICA HPS - Tibial Liner #7 H. 14 mm - LimaVit
• 08033390212861: PHYSICA HPS - Tibial Liner #7 H. 12 mm - LimaVit
• 08033390212854: PHYSICA HPS - Tibial Liner #7 H. 11 mm - LimaVit
• 08033390212830: PHYSICA HPS - Tibial Liner #6 H. 20 mm - LimaVit
• 08033390212823: PHYSICA HPS - Tibial Liner #6 H. 16 mm - LimaVit
• 08033390212816: PHYSICA HPS - Tibial Liner #6 H. 14 mm - LimaVit
• 08033390212809: PHYSICA HPS - Tibial Liner #6 H. 12 mm - LimaVit
• 08033390212793: PHYSICA HPS - Tibial Liner #6 H. 11 mm - LimaVit
• 08033390212786: PHYSICA HPS - Tibial Liner #6 H. 10 mm - LimaVit
• 08033390212779: PHYSICA HPS - Tibial Liner #5 H. 20 mm - LimaVit
• 08033390212762: PHYSICA HPS - Tibial Liner #5 H. 16 mm - LimaVit
• 08033390212755: PHYSICA HPS - Tibial Liner #5 H. 14 mm - LimaVit
• 08033390212748: PHYSICA HPS - Tibial Liner #5 H. 12 mm - LimaVit
• 08033390212731: PHYSICA HPS - Tibial Liner #5 H. 11 mm - LimaVit
• 08033390212724: PHYSICA HPS - Tibial Liner #5 H. 10 mm - LimaVit
• 08033390212717: PHYSICA HPS - Tibial Liner #4 H. 20 mm - LimaVit
• 08033390212700: PHYSICA HPS - Tibial Liner #4 H. 16 mm - LimaVit
• 08033390212694: PHYSICA HPS - Tibial Liner #4 H. 14 mm - LimaVit
• 08033390212687: PHYSICA HPS - Tibial Liner #4 H. 12 mm - LimaVit
• 08033390212670: PHYSICA HPS - Tibial Liner #4 H. 11 mm - LimaVit
• 08033390212663: PHYSICA HPS - Tibial Liner #4 H. 10 mm - LimaVit
• 08033390212656: PHYSICA HPS - Tibial Liner #3 H. 20 mm - LimaVit
• 08033390212649: PHYSICA HPS - Tibial Liner #3 H. 16 mm - LimaVit
• 08033390212632: PHYSICA HPS - Tibial Liner #3 H. 14 mm - LimaVit
• 08033390212625: PHYSICA HPS - Tibial Liner #3 H. 12 mm - LimaVit
• 08033390212618: PHYSICA HPS - Tibial Liner #3 H. 11 mm - LimaVit
• 08033390212601: PHYSICA HPS - Tibial Liner #3 H. 10 mm - LimaVit
• 08033390212595: PHYSICA HPS - Tibial Liner #2 H. 20 mm - LimaVit
• 08033390212588: PHYSICA HPS - Tibial Liner #2 H. 16 mm - LimaVit
• 08033390212571: PHYSICA HPS - Tibial Liner #2 H. 14 mm - LimaVit
• 08033390212564: PHYSICA HPS - Tibial Liner #2 H. 12 mm - LimaVit