Born PT-LIF Cage HA— 510(k) K202380

Name: FDA 510(k) clearance K202380
Creator: U.S. Food and Drug Administration
Published: 2021-02-19

Substantially Equivalent

Spineworxx AG

FDA 510(k) clearance K202380 for Born PT-LIF Cage HA, Substantially Equivalent on 2021-02-19. Applicant: Spineworxx AG. Device class: 2.

Clearance details

Applicant: Spineworxx AG
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-08-20
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Gallen, CH

Download summary PDF View 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, 2020-01-01 through 2026-04-23. 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.