PhantomMSK Trauma— 510(k) K192279

Name: FDA 510(k) clearance K192279
Creator: U.S. Food and Drug Administration
Published: 2019-12-07

Substantially Equivalent

OrthoGrid Systems, Inc.

FDA 510(k) clearance K192279 for PhantomMSK Trauma, Substantially Equivalent on 2019-12-07. Applicant: OrthoGrid Systems, Inc.. Device class: 2.

Clearance details

Applicant: OrthoGrid Systems, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-08-22
Decision date: 2019-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from OrthoGrid Systems, Inc.

view all

K260077 — OrthoGrid Hip AI® 4.02026-05-29
K210136 — PhantomMSK Hip2021-02-18
K182332 — PhantomMSK2019-02-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.