PYRENEES Cervical Plate System SP-872

GUDID 10888857289710

Drill Guide, Variable

K2M, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10888857289710
• NIH Device Record Key: 30a18f3a-349c-48b5-bec3-6a708796609b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRENEES Cervical Plate System
• Version Model Number: SP-872
• Catalog Number: SP-872
• 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(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 Identifiers

Device Issuing Agency	Device ID
GS1	10888857289710 [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

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

[10888857289710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-08
• Device Publish Date: 2024-04-30

On-Brand Devices [PYRENEES Cervical Plate System]

• 10888857171565: Clip
• 10888857113312: Tap with Stop Size 10 mm
• 10888857113268: Anti-Torque Guide
• 10888857113237: Tap Size 10 mm
• 10888857113220: Awl Size 10 mm
• 10888857113213: Drill Size Ø3.0x16 mm
• 10888857113206: Drill Size Ø3.0x14 mm
• 10888857113190: Drill Size Ø3.0x12 mm
• 10888857030558: Clip Size 1 mm
• 10888857247314: Retaining Driver Size 13
• 10888857030480: Fast Awl Size 10 mm
• 10888857030350: Capture Driver, Sleeve Size 10
• 10888857030299: Torque Limiting Handle Size 20 in-lbs (2.3 N-m)
• 10888857030275: Drill, No Trocar Size Ø2.3x14 mm
• 10888857030268: Drill, No Trocar Size Ø2.3x12 mm
• 10888857030251: Drill, No Trocar Size Ø2.3x10 mm
• 10888857030244: Non-Tapered Torque Driver Size 10
• 10888857030220: Non-Tapered Torque Driver
• 10888857030213: Spring Loaded Awl Size 10 mm
• 10888857030190: Screw Extractor
• 10888857030183: Tapered Driver Size 10
• 10888857030176: Freehand Tap Size Ø2.3x10 mm
• 10888857030169: Tap Size Ø2.3x10 mm
• 10888857030152: Awl Size 10 mm
• 10888857030145: Temporary Pin Inserter
• 10888857030138: Drill Size Ø2.3x16 mm
• 10888857030121: Drill Size Ø2.3x14 mm
• 10888857030114: Drill Size Ø2.3x12 mm
• 10888857030107: Drill Size Ø2.3x10 mm
• 10888857030091: Thread Former
• 10888857030039: Drill Size Ø2.3x16 mm
• 10888857030022: Drill Size Ø2.3x14 mm
• 10888857030015: Drill Size Ø2.3x12 mm
• 10888857030008: Drill Size Ø2.3x10 mm
• 10888857029989: Torque Limiting Handle (1/4" Square Quick Connect)
• 10888857029972: Plate Bender, Cervical Universal
• 10888857029941: Reduction Screw Size 14 mm
• 10888857029934: Reduction Screw Size 12 mm
• 10888857029910: Caliper
• 10888857029859: Freehand Tap Size Ø4.0x10 mm
• 10888857029842: Temporary Fixation Pin
• 10888857029835: Spring Loaded Awl Size 10 mm
• 10888857029828: Tap Size Ø4.0x10 mm
• 10888857029781: 2.3mm Stop Drill Size 10mm
• 10888857029682: Awl Size 10 mm
• 10888857029675: 2.3mm Stop Drill Size 16mm
• 10888857029668: 2.3mm Stop Drill Size 14mm
• 10888857029651: 2.3mm Stop Drill Size 12mm
• 10888857029637: Screw Extractor
• 10888857260498: Tap Size ø2.3mm x 16mm