PhantomMSK Hip— 510(k) K210136

Name: FDA 510(k) clearance K210136
Creator: U.S. Food and Drug Administration
Published: 2021-02-18

Substantially Equivalent

OrthoGrid Systems, Inc.

FDA 510(k) clearance K210136 for PhantomMSK Hip, Substantially Equivalent on 2021-02-18. 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: 2021-01-19
Decision date: 2021-02-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K260077 — OrthoGrid Hip AI® 4.02026-05-29
K192279 — PhantomMSK Trauma2019-12-07
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.