K2M Patient Specific 2601-901BAC

GUDID 10888857413269

Rod Template

K2M, INC.

Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10888857413269
• NIH Device Record Key: d9093bae-b780-4837-8cf5-66e083efb1b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Patient Specific
• Version Model Number: 2601-901BAC
• Catalog Number: 2601-901BAC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857413269 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[10888857413269]

Moist Heat or Steam Sterilization

[10888857413269]

Moist Heat or Steam Sterilization

[10888857413269]

Moist Heat or Steam Sterilization

[10888857413269]

Moist Heat or Steam Sterilization

[10888857413269]

Moist Heat or Steam Sterilization

[10888857413269]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [K2M Patient Specific]

• 10888857413054: Contoured, Deformity, MESA Rail CoCr
• 10888857413047: Contoured, Deformity, MESA Rail Ti
• 10888857413030: Contoured Deformity Rod, Size Ø5.5 CoCr
• 10888857413023: Contoured Deformity Rod, Size Ø5.5 Ti
• 10888857548701: Contoured Deformity Rod Size Ø6.0 CoCr
• 10888857548695: Contoured Deformity Rod Size Ø6.0 Ti
• 10888857413269: Rod Template