Catalyft PL Expandable Interbody System— 510(k) K253011
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K253011 for Catalyft PL Expandable Interbody System, Substantially Equivalent on 2026-07-17. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.
Summary
Medtronic Sofamor Danek USA's Catalyft PL Expandable Interbody System is filed under MAX, lumbar intervertebral fusion devices with bone graft. The record doesn't expand "PL" or give sizes.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Medtronic filed from Memphis, Tennessee. The decision came 301 calendar days after FDA received it (September 19, 2025 to July 17, 2026).
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code MAX
view allMore clearances from Medtronic Sofamor Danek USA, Inc.
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.