NAPA® MI Retractor System 1601-90013

GUDID 10888857020658

G15 Articulated Arm

K2M, INC.

Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable Surgical retraction system mounting frame, reusable

• Primary Device ID: 10888857020658
• NIH Device Record Key: 958c2c75-b87b-4d2c-988a-951ec9d4a7b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAPA® MI Retractor System
• Version Model Number: 1601-90013
• Catalog Number: 1601-90013
• 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	10888857020658 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

[10888857020658]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

Devices Manufactured by K2M, INC.

• 10888857562035 - ATP Disc Prep: 2024-04-12 Pituitary ATP, 3mm
• 10888857562042 - ATP Disc Prep: 2024-04-12 Pituitary ATP, 5mm
• 10888857574304 - YUKON OCT Spinal System: 2024-04-02 Tap Ø3.0 mm
• 10888857574311 - YUKON OCT Spinal System: 2024-04-02 Tap Ø3.5 mm
• 10888857574328 - YUKON OCT Spinal System: 2024-04-02 Tap Ø4.0 mm
• 10888857574335 - YUKON OCT Spinal System: 2024-04-02 Tap Ø4.5 mm
• 10888857574342 - YUKON OCT Spinal System: 2024-04-02 Tap Ø5.0 mm
• 10888857556218 - ATP Disc Prep: 2024-03-28 Box Chisel ATP, 6mm