Oasys® PRO-1222

GUDID 10888857551824

Inserter

K2M, INC.

Surgical screwdriver, reusable

• Primary Device ID: 10888857551824
• NIH Device Record Key: 1ef802e3-ae60-4034-9149-5cbb1bb1c4e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oasys®
• Version Model Number: PRO-1222
• Catalog Number: PRO-1222
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857551824 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[10888857551824]

Moist Heat or Steam Sterilization

[10888857551824]

Moist Heat or Steam Sterilization

[10888857551824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

Devices Manufactured by K2M, INC.

• 10888857551824 - Oasys®: 2025-01-23Inserter
• 10888857551824 - Oasys®: 2025-01-23 Inserter
• 10888857007529 - DENALI® Spinal System: 2025-01-21 Lateral Offset Connector Size 50 mm
• 10888857008502 - DENALI® Spinal System: 2025-01-21 Buttress Ring Size Ø5.5 mm
• 10888857525801 - CASCADIA™ Interbody System: 2024-11-12 AN Inserter Inner Shaft
• 10888857525818 - CASCADIA™ Interbody System: 2024-11-12 AN Lordotic - Oblique Inserter Size 10 mm
• 10888857006072 - DENALI® Spinal System: 2024-11-06 Straight Rod Size Ø5.5x110 mm Ti
• 10888857006256 - DENALI® Spinal System: 2024-11-06 Straight Rod Size Ø5.5x45 mm Ti
• 10888857006324 - DENALI® Spinal System: 2024-11-06 Straight Rod Size Ø5.5x55 mm Ti