Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

e-Ortho Shoulder Software v1.1

K-Number: K220758 · 2022-09-30

ApplicantFH Industrie
Decision Date2022-09-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

e-Ortho Shoulder Software v1.1 is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K220758. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the e-Ortho Shoulder Software v1.1?

e-Ortho Shoulder Software v1.1 is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is FH Industrie. The 510(k) number is K220758.

When did e-Ortho Shoulder Software v1.1 receive FDA 510(k) clearance?

e-Ortho Shoulder Software v1.1 received FDA 510(k) clearance on 2022-09-30, under 510(k) number K220758.

Who is the listed applicant for e-Ortho Shoulder Software v1.1?

The FDA 510(k) record lists FH Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-Ortho Shoulder Software v1.1?

The FDA product code for e-Ortho Shoulder Software v1.1 is LLZ.

Other records listing FH Industrie as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254003JARVIS Metaphyseal StemK253345JARVIS Diaphyseal Stem StandardK252411JARVIS Glenoid Reverse Shoulder ProsthesisK242253JARVIS Glenoid Reverse Shoulder ProsthesisK232226ARROW Off-Centred Humeral InsertK202024ARROW Short Stem Humeral System

View all 9 devices →

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑