Monterey™ AL PRO-1418-02

GUDID 10888857586932

M/L AL Implant Inserter 10/12 mm

K2M, INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 10888857586932
• NIH Device Record Key: a02d5966-22d4-4393-8e2e-0406ce03a0d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monterey™ AL
• Version Model Number: PRO-1418-02
• Catalog Number: PRO-1418-02
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857586932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201585

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

[10888857586932]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-25
• Device Publish Date: 2025-06-17

On-Brand Devices [Monterey™ AL]

• 10888857588301: Cam Lock Driver
• 10888857586970: M/L AL Implant Inserter 18/20 mm
• 10888857586963: C/C AL Implant Inserter 18/20 mm
• 10888857586956: M/L AL Implant Inserter 14/16 mm
• 10888857586949: C/C AL Implant Inserter 14/16 mm
• 10888857586932: M/L AL Implant Inserter 10/12 mm
• 10888857586925: C/C AL Implant Inserter 10/12 mm
• 10888857586918: M/L AL Trial Inserter
• 10888857586901: C/C AL Trial Inserter