PHYSICA KR 6511.09.5A0

GUDID 08033390087391

KR Femoral Component Left #10

LIMACORPORATE SPA

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 08033390087391
• NIH Device Record Key: 2a341c90-6b6e-44b2-aebc-5c059c1fd841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHYSICA KR
• Version Model Number: Left Femoral Comp.
• Catalog Number: 6511.09.5A0
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390087391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141934

FDA Product Code

• HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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: 2019-12-11
• Device Publish Date: 2015-08-04

On-Brand Devices [PHYSICA KR]

• 08033390087391: KR Femoral Component Left #10
• 08033390087384: KR Femoral Component Left #9
• 08033390087377: KR Femoral Component Left #8
• 08033390087360: KR Femoral Component Left #7
• 08033390087353: KR Femoral Component Left #6
• 08033390087346: KR Femoral Component Left #5
• 08033390087339: KR Femoral Component Left #4
• 08033390087322: KR Femoral Component Left #3
• 08033390087315: KR Femoral Component Left #2
• 08033390087308: KR Femoral Component Left #1
• 08033390087292: KR Femoral Component Right #10
• 08033390087285: KR Femoral Component Right #9
• 08033390087278: KR Femoral Component Right #8
• 08033390087261: KR Femoral Component Right #7
• 08033390087254: KR Femoral Component Right #6
• 08033390087247: KR Femoral Component Right #5
• 08033390087230: KR Femoral Component Right #4
• 08033390087223: KR Femoral Component Right #3
• 08033390087216: KR Femoral Component Right #2
• 08033390083089: KR Femoral Component Right #1
• 08033390182904: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 20 mm Right
• 08033390182898: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 16 mm Right
• 08033390182881: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 14 mm Right
• 08033390182850: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 12 mm Right
• 08033390182843: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 11 mm Right
• 08033390182836: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #8 H. 10 mm Right
• 08033390182829: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 20 mm Right
• 08033390182812: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 16 mm Right
• 08033390182805: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 14 mm Right
• 08033390182713: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 12 mm Right
• 08033390182706: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 11 mm Right
• 08033390182690: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #7 H. 10 mm Right
• 08033390182683: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 20 mm Right
• 08033390182614: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 16 mm Right
• 08033390182607: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 14 mm Right
• 08033390182591: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 12 mm Right
• 08033390182584: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 11 mm Right
• 08033390182577: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #6 H. 10 mm Right
• 08033390182560: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 20 mm Right
• 08033390182553: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 16 mm Right
• 08033390182546: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 14 mm Right
• 08033390182539: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 12 mm Right
• 08033390182522: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 11 mm Right
• 08033390182515: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #5 H. 10 mm Right
• 08033390182416: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 20 mm Right
• 08033390182379: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 16 mm Right
• 08033390182362: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 14 mm Right
• 08033390182294: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 12 mm Right
• 08033390182287: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 11 mm Right
• 08033390182270: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 10 mm Right