Oryx™ AP242

GUDID M711AP2420

Ti 6Al 4V (ELI)

Innovasis, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M711AP2420
• NIH Device Record Key: 4ef6fdf7-63d4-4ba6-ac7f-3bf09714851b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oryx™
• Version Model Number: AP242
• Catalog Number: AP242
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: false
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711AP2420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192049

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

[M711AP2420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [Oryx™]

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• M711APV45180: Ti 6Al 4V (ELI)
• M711APV45160: Ti 6Al 4V (ELI)
• M711APV45140: Ti 6Al 4V (ELI)
• M711APV45120: Ti 6Al 4V (ELI)
• M711APV40200: Ti 6Al 4V (ELI)
• M711APV40190: Ti 6Al 4V (ELI)
• M711APV40180: Ti 6Al 4V (ELI)
• M711APV40170: Ti 6Al 4V (ELI)
• M711APV40160: Ti 6Al 4V (ELI)
• M711APV40150: Ti 6Al 4V (ELI)
• M711APV40140: Ti 6Al 4V (ELI)
• M711APV40130: Ti 6Al 4V (ELI)
• M711APV40120: Ti 6Al 4V (ELI)
• M711APF45200: Ti 6Al 4V (ELI)
• M711APF45180: Ti 6Al 4V (ELI)
• M711APF45160: Ti 6Al 4V (ELI)
• M711APF45140: Ti 6Al 4V (ELI)
• M711APF45120: Ti 6Al 4V (ELI)
• M711APF40200: Ti 6Al 4V (ELI)
• M711APF40190: Ti 6Al 4V (ELI)
• M711APF40180: Ti 6Al 4V (ELI)
• M711APF40170: Ti 6Al 4V (ELI)
• M711APF40160: Ti 6Al 4V (ELI)
• M711APF40150: Ti 6Al 4V (ELI)
• M711APF40140: Ti 6Al 4V (ELI)
• M711APF40130: Ti 6Al 4V (ELI)
• M711APF40120: Ti 6Al 4V (ELI)
• M711AP4850: Ti 6Al 4V (ELI)
• M711AP4820: Ti 6Al 4V (ELI)
• M711AP4790: Ti 6Al 4V (ELI)
• M711AP4760: Ti 6Al 4V (ELI)
• M711AP4730: Ti 6Al 4V (ELI)
• M711AP4700: Ti 6Al 4V (ELI)
• M711AP4670: Ti 6Al 4V (ELI)
• M711AP4640: Ti 6Al 4V (ELI)
• M711AP4610: Ti 6Al 4V (ELI)
• M711AP4580: Ti 6Al 4V (ELI)
• M711AP4550: Ti 6Al 4V (ELI)
• M711AP4520: Ti 6Al 4V (ELI)
• M711AP3660: Ti 6Al 4V (ELI)
• M711AP3630: Ti 6Al 4V (ELI)
• M711AP3600: Ti 6Al 4V (ELI)
• M711AP3570: Ti 6Al 4V (ELI)
• M711AP3540: Ti 6Al 4V (ELI)
• M711AP3510: Ti 6Al 4V (ELI)
• M711AP3480: Ti 6Al 4V (ELI)
• M711AP3450: Ti 6Al 4V (ELI)
• M711AP3420: Ti 6Al 4V (ELI)
• M711AP2460: Ti 6Al 4V (ELI)