APEX Revision Knee KP-39020

GUDID 00841690121497

PS Revision Tibial Locking Bolt Modular Tibia - 20mm

Omnilife Science, Inc

Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00841690121497
• NIH Device Record Key: 9f426a6f-f81f-452d-9b98-1be8a3357de1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX Revision Knee
• Version Model Number: KP-39020
• Catalog Number: KP-39020
• Company DUNS: 061339651
• Company Name: Omnilife Science, Inc
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841690121497 [Primary]

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

[00841690121497]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-11-27

On-Brand Devices [APEX Revision Knee]

• 00841690126355: Femoral Augment Distal, Size 5+ Right, 10mm
• 00841690126348: Femoral Augment Distal, Size 5+ Left, 10mm
• 00841690126331: Femoral Augment Posterior, Size 5+, 10mm
• 00841690126324: Femoral Augment Distal, Size 5+ Right, 5mm
• 00841690126317: Femoral Augment Distal, Size 5+ Left, 5mm
• 00841690126300: Femoral Augment Posterior, Size 5+, 5mm
• 00841690125204: Femoral Augment Distal, Size 4+ Right, 10mm
• 00841690125198: Femoral Augment Distal, Size 4+ Left, 10mm
• 00841690125181: Femoral Augment Posterior, Size 4+, 10mm
• 00841690125174: Femoral Augment Distal, Size 4+ Right, 5mm
• 00841690125167: Femoral Augment Distal, Size 4+ Left, 5mm
• 00841690125150: Femoral Augment Posterior, Size 4+, 5mm
• 00841690124795: Modular Stem 17mm x 125mm
• 00841690124788: Modular Stem 15mm x 125mm
• 00841690124771: Modular Stem 13mm x 125mm
• 00841690124764: Modular Stem 11mm x 125mm
• 00841690124757: Modular Stem 9mm x 125mm
• 00841690124726: Modular Offset Stem 9mm x 75mm x 4mm
• 00841690124719: Modular Offset Stem 9mm x 75mm x 2mm
• 00841690124702: Modular Offset Stem 9mm x 150mm x 4mm
• 00841690124696: Modular Offset Stem 9mm x 150mm x 2mm
• 00841690124689: Modular Offset Stem 9mm x 125mm 4mm
• 00841690124672: Modular Offset Stem 9mm x 125mm 2mm
• 00841690124665: Modular Offset Stem 9mm x 100mm x 4mm
• 00841690124658: Modular Offset Stem 9mm x 100mm x 2mm
• 00841690124641: Modular Offset Stem 17mm x 75mm x 4mm
• 00841690124634: Modular Offset Stem 17mm x 75mm x 2mm
• 00841690124627: Modular Offset Stem 17mm x 150mm x 4mm
• 00841690124610: Modular Offset Stem 17mm x 150mm x 2mm
• 00841690124603: Modular Offset Stem 17mm x 125mm 4mm
• 00841690124597: Modular Offset Stem 17mm x 125mm 2mm
• 00841690124580: Modular Offset Stem 17mm x 100mm x 4mm
• 00841690124573: Modular Offset Stem 17mm x 100mm x 2mm
• 00841690124474: Modular Offset Stem 15mm x 75mm x 4mm
• 00841690124467: Modular Offset Stem 15mm x 75mm x 2mm
• 00841690124450: Modular Offset Stem 15mm x 150mm x 4mm
• 00841690124443: Modular Offset Stem 15mm x 150mm x 2mm
• 00841690124436: Modular Offset Stem 15mm x 125mm 4mm
• 00841690124429: Modular Offset Stem 15mm x 125mm 2mm
• 00841690124412: Modular Offset Stem 15mm x 100mm x 4mm
• 00841690124405: Modular Offset Stem 15mm x 100mm x 2mm
• 00841690124313: Modular Offset Stem 13mm x 75mm x 4mm
• 00841690124306: Modular Offset Stem 13mm x 75mm x 2mm
• 00841690124290: Modular Offset Stem 13mm x 150mm x 4mm
• 00841690124283: Modular Offset Stem 13mm x 150mm x 2mm
• 00841690124276: Modular Offset Stem 13mm x 125mm 4mm
• 00841690124269: Modular Offset Stem 13mm x 125mm 2mm
• 00841690124252: Modular Offset Stem 13mm x 100mm x 4mm
• 00841690124245: Modular Offset Stem 13mm x 100mm x 2mm
• 00841690124153: Modular Offset Stem 11mm x 75mm x 4mm