PYRENEES® Cervical Plate System 201-90029

GUDID 10888857029866

Plate Holder, Cervical, Size Cervical

K2M, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10888857029866
• NIH Device Record Key: bed08266-d1b0-4d74-a4e0-47f4beba4298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRENEES® Cervical Plate System
• Version Model Number: 201-90029
• Catalog Number: 201-90029
• 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: false
• 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
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857029866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142212

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

Moist Heat or Steam Sterilization

[10888857029866]

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: 2016-09-16

On-Brand Devices [PYRENEES® Cervical Plate System]

• 10888857432413: Plate Holder
• 10888857427525: Adjustable Drill Guide
• 10888857412408: Double Barrel Drill Guide
• 10888857412392: Single Barrel Drill Guide, Fixed
• 10888857381735: Plate Holder
• 10888857327139: Screw, Self-Tapping, Size Ø5.0x26 mm
• 10888857327122: Screw, Self-Tapping, Size Ø5.0x24 mm
• 10888857327115: Screw, Self-Tapping, Size Ø4.75x26 mm
• 10888857327108: Screw, Self-Tapping, Size Ø4.75x24 mm
• 10888857327092: Screw, Self-Tapping, Size Ø4.5x26 mm
• 10888857327085: Screw, Self-Tapping, Size Ø4.5x24 mm
• 10888857327078: Screw, Self-Tapping, Size Ø5.0x26 mm
• 10888857327061: Screw, Self-Tapping, Size Ø5.0x24 mm
• 10888857327054: Screw, Self-Tapping, Size Ø4.75x26 mm
• 10888857327047: Screw, Self-Tapping, Size Ø4.75x24 mm
• 10888857327030: Screw, Self-Tapping, Size Ø4.5x26 mm
• 10888857327023: Screw, Self-Tapping, Size Ø4.5x24 mm
• 10888857320727: Variable Drill Guide, Size Long
• 10888857306899: Self-Starting Screw, Constrained, Size Ø3.85 mm, 26 mm
• 10888857306882: Self-Starting Screw, Constrained, Size Ø3.85 mm, 24 mm
• 10888857306875: Self-Starting Screw, Constrained, Size Ø3.85 mm, 22 mm
• 10888857306868: Self-Starting Screw, Constrained, Size Ø3.85 mm, 20 mm
• 10888857306851: Self-Starting Screw, Constrained, Size Ø3.85 mm, 18 mm
• 10888857306844: Self-Starting Screw, Constrained, Size Ø3.85 mm, 16 mm
• 10888857306837: Self-Starting Screw, Constrained, Size Ø3.85 mm, 14 mm
• 10888857306820: Self-Starting Screw, Constrained, Size Ø3.85 mm, 12 mm
• 10888857306813: Self-Starting Screw, Constrained, Size Ø3.85 mm, 10 mm
• 10888857306806: Self-Starting Screw, Constrained, Size Ø3.5 mm, 26 mm
• 10888857306790: Self-Starting Screw, Constrained, Size Ø3.5 mm, 24 mm
• 10888857306783: Self-Starting Screw, Constrained, Size Ø3.5 mm, 22 mm
• 10888857306776: Self-Starting Screw, Constrained, Size Ø3.5 mm, 20 mm
• 10888857303997: Single Level Plate, 4 Screw, Size Ø4.0 mm, 9 mm
• 10888857303980: Single Level Plate, 4 Screw, Size Ø4.0 mm, 8 mm
• 10888857303973: Single Level Plate, 4 Screw, Size Ø4.0 mm, 7 mm
• 10888857303966: Single Level Plate, 4 Screw, Size Ø4.0 mm, 6 mm
• 10888857303959: Single Level Plate, 4 Screw, Size Ø4.0 mm, 5 mm
• 10888857303942: Single Level Plate, 4 Screw, Size Ø4.0 mm, 15 mm
• 10888857303935: Single Level Plate, 4 Screw, Size Ø4.0 mm, 14 mm
• 10888857303928: Single Level Plate, 4 Screw, Size Ø4.0 mm, 13 mm
• 10888857303911: Single Level Plate, 4 Screw, Size Ø4.0 mm, 12 mm
• 10888857303904: Single Level Plate, 4 Screw, Size Ø4.0 mm, 11 mm
• 10888857303898: Single Level Plate, 4 Screw, Size Ø4.0 mm, 10 mm
• 10888857303881: Single Level Plate, 3 Screw, Size Ø4.0 mm, 9 mm
• 10888857303874: Single Level Plate, 3 Screw, Size Ø4.0 mm, 8 mm
• 10888857303867: Single Level Plate, 3 Screw, Size Ø4.0 mm, 7 mm
• 10888857303850: Single Level Plate, 3 Screw, Size Ø4.0 mm, 6 mm
• 10888857303843: Single Level Plate, 3 Screw, Size Ø4.0 mm, 5 mm
• 10888857303836: Single Level Plate, 3 Screw, Size Ø4.0 mm, 15 mm
• 10888857303829: Single Level Plate, 3 Screw, Size Ø4.0 mm, 14 mm
• 10888857303812: Single Level Plate, 3 Screw, Size Ø4.0 mm, 13 mm