DeviceClearance

Catalyft LS Expandable Interbody System— 510(k) K212653

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K212653 for Catalyft LS Expandable Interbody System, Substantially Equivalent on 2021-11-19. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic Sofamor Danek USA, Inc.
Product code
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
Download summary PDFView on FDA.gov ↗

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Adverse 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 →

Recalls naming K212653

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212653.

Data sourced from openFDA. This site is unofficial and independent of the FDA.