OZARK Cervical Plate System 8801-14319CA-G1

GUDID 10888857407534

Fixed Screw, Self-Tapping, Size Ø4.35x19 mm

K2M, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10888857407534
• NIH Device Record Key: c80fab32-e552-4fc9-8816-ac7c00f03083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OZARK Cervical Plate System
• Version Model Number: 8801-14319CA-G1
• Catalog Number: 8801-14319CA-G1
• Company DUNS: 146060863
• Company Name: K2M, 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: 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(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(703)777-3155
• Email: ngiezen@k2m.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter
• Outer Diameter: 4.35 Millimeter
• Length: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857407534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172104

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

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: 2019-01-14
• Device Publish Date: 2018-12-12

On-Brand Devices [OZARK Cervical Plate System]

• 10888857417779: Plate, 5 Level, Size 110 mm
• 10888857417762: Plate, 5 Level, Size 109 mm
• 10888857417755: Plate, 5 Level, Size 108 mm
• 10888857417748: Plate, 5 Level, Size 107 mm
• 10888857417731: Plate, 5 Level, Size 106 mm
• 10888857417724: Plate, 5 Level, Size 105 mm
• 10888857417717: Plate, 5 Level, Size 104 mm
• 10888857417700: Plate, 5 Level, Size 103 mm
• 10888857417694: Plate, 5 Level, Size 102 mm
• 10888857417687: Plate, 5 Level, Size 101 mm
• 10888857417670: Plate, 5 Level, Size 100 mm
• 10888857417663: Plate, 5 Level, Size 99 mm
• 10888857417656: Plate, 5 Level, Size 98 mm
• 10888857417649: Plate, 5 Level, Size 97 mm
• 10888857417632: Plate, 5 Level, Size 96 mm
• 10888857417625: Plate, 5 Level, Size 95 mm
• 10888857417618: Plate, 5 Level, Size 94 mm
• 10888857417601: Plate, 5 Level, Size 93 mm
• 10888857417595: Plate, 5 Level, Size 92 mm
• 10888857417588: Plate, 5 Level, Size 91 mm
• 10888857417571: Plate, 5 Level, Size 90 mm
• 10888857417564: Plate, 4 Level, Size 101 mm
• 10888857417557: Plate, 4 Level, Size 100 mm
• 10888857417540: Plate, 4 Level, Size 99 mm
• 10888857417533: Plate, 4 Level, Size 98 mm
• 10888857417526: Plate, 4 Level, Size 97 mm
• 10888857417519: Plate, 4 Level, Size 96 mm
• 10888857417502: Plate, 4 Level, Size 95 mm
• 10888857417496: Plate, 4 Level, Size 94 mm
• 10888857417489: Plate, 4 Level, Size 93 mm
• 10888857417472: Plate, 4 Level, Size 92 mm
• 10888857417465: Plate, 4 Level, Size 91 mm
• 10888857417458: Plate, 4 Level, Size 90 mm
• 10888857417441: Plate, 4 Level, Size 89 mm
• 10888857417434: Plate, 4 Level, Size 88 mm
• 10888857417427: Plate, 4 Level, Size 87 mm
• 10888857417410: Plate, 4 Level, Size 86 mm
• 10888857417403: Plate, 4 Level, Size 85 mm
• 10888857417397: Plate, 4 Level, Size 84 mm
• 10888857417380: Plate, 4 Level, Size 83 mm
• 10888857417373: Plate, 4 Level, Size 82 mm
• 10888857417366: Plate, 4 Level, Size 81 mm
• 10888857417359: Plate, 4 Level, Size 80 mm
• 10888857417342: Plate, 4 Level, Size 79 mm
• 10888857417335: Plate, 4 Level, Size 78 mm
• 10888857417328: Plate, 4 Level, Size 77 mm
• 10888857417311: Plate, 4 Level, Size 76 mm
• 10888857417304: Plate, 4 Level, Size 75 mm
• 10888857417298: Plate, 4 Level, Size 74 mm
• 10888857417281: Plate, 4 Level, Size 73 mm