CAYMAN® Plate System 1208-41F38S

GUDID 10888857019133

Sacral Plate

K2M, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10888857019133
• NIH Device Record Key: 354d0249-baa6-4774-a66d-5857631a1567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAYMAN® Plate System
• Version Model Number: 1208-41F38S
• Catalog Number: 1208-41F38S
• 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: 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: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com

Device Dimensions

• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter
• Length: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857019133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091253

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

[10888857019133]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [CAYMAN® Plate System]

• 10888857093522: Screw
• 10888857093447: Screw
• 10888857093362: Screw
• 10888857093287: Screw
• 10888857093201: Screw
• 10888857020085: Buttress Plate, Size 30 mm
• 10888857020054: Buttress Plate
• 10888857020047: Buttress Plate
• 10888857020030: Buttress Plate
• 10888857019577: Lumbar Plate
• 10888857019560: Lumbar Plate
• 10888857019553: Lumbar Plate
• 10888857019546: Lumbar Plate
• 10888857019539: Lumbar Plate
• 10888857019522: Lumbar Plate
• 10888857019515: Lumbar Plate
• 10888857019508: Sacral Plate
• 10888857019492: Sacral Plate
• 10888857019485: Sacral Plate
• 10888857019478: Sacral Plate
• 10888857019461: Sacral Plate
• 10888857019454: Sacral Plate
• 10888857019447: Sacral Plate
• 10888857019430: Sacral Plate
• 10888857019423: Lumbar Plate
• 10888857019416: Thoracolumbar Plate
• 10888857019409: Thoracolumbar Plate
• 10888857019393: Thoracolumbar Plate
• 10888857019386: Thoracolumbar Plate
• 10888857019379: Thoracolumbar Plate
• 10888857019362: Thoracolumbar Plate
• 10888857019355: Thoracolumbar Plate
• 10888857019348: Thoracolumbar Plate
• 10888857019331: Thoracolumbar Plate
• 10888857019324: Thoracolumbar Plate
• 10888857019317: Thoracolumbar Plate
• 10888857019300: Thoracolumbar Plate
• 10888857019294: Thoracolumbar Plate
• 10888857019287: Thoracolumbar Plate
• 10888857019270: Thoracolumbar Plate
• 10888857019263: Thoracolumbar Plate
• 10888857019256: Thoracolumbar Plate
• 10888857019249: Sacral Plate
• 10888857019232: Lumbar Plate
• 10888857019225: Thoracolumbar Plate
• 10888857019218: Sacral Plate
• 10888857019201: Lumbar Plate
• 10888857019195: Thoracolumbar Plate
• 10888857019188: Sacral Plate
• 10888857019171: Lumbar Plate