KEYS™ MI Anterior Deformity Spinal System 4601-90061

GUDID 10888857403888

Fixed Handle

K2M, INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 10888857403888
• NIH Device Record Key: 0f869977-f19d-45b9-b760-baa85d276fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KEYS™ MI Anterior Deformity Spinal System
• Version Model Number: 4601-90061
• Catalog Number: 4601-90061
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	10888857403888 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

[10888857403888]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

On-Brand Devices [KEYS™ MI Anterior Deformity Spinal System]

• 10888857403888: Fixed Handle
• 10888857383081: Inner Shaft, Threaded