INJECTION PIN (KIP(02031-02061) (03031-03061))— 510(k) K221697

Name: FDA 510(k) clearance K221697
Creator: U.S. Food and Drug Administration
Published: 2023-03-03

Substantially Equivalent

Slk Ortho, LLC

FDA 510(k) clearance K221697 for INJECTION PIN (KIP(02031-02061) (03031-03061)), Substantially Equivalent on 2023-03-03. Applicant: Slk Ortho, LLC. Device class: 2.

Clearance details

Applicant: Slk Ortho, LLC
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2022-06-10
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Grove, IL, US

Download summary PDF View on FDA.gov ↗

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K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System2025-04-11
K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement2024-09-18
K232842 — Balloon Inflation System2024-02-29

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.