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Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214011
510(k) Type
Special
Applicant
Medtronic Sofamor Danek USA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2022
Days to Decision
49 days
Submission Type
Summary

Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214011
510(k) Type
Special
Applicant
Medtronic Sofamor Danek USA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/9/2022
Days to Decision
49 days
Submission Type
Summary