EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods— 510(k) K222473

Name: FDA 510(k) clearance K222473
Creator: U.S. Food and Drug Administration
Published: 2022-10-13

Substantially Equivalent

Medos-International Sarl

FDA 510(k) clearance K222473 for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods, Substantially Equivalent on 2022-10-13. Applicant: Medos-International Sarl. Device class: 2.

Clearance details

Applicant: Medos-International Sarl
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2022-08-16
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Download summary PDF View on FDA.gov ↗

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K263172 — SAS MIS Pelvic Incidence Rods2026-09-30

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Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.