FDA 510(k)

e-Ortho Shoulder Software v1.1

K-Number: K220758 · 2022-09-30

Decision Date2022-09-30

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

e-Ortho Shoulder Software v1.1 is a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2022-09-30 under approval 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. It is manufactured by FH Industrie. The 510(k) number is K220758.

When was e-Ortho Shoulder Software v1.1 approved by the FDA?

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

What company makes e-Ortho Shoulder Software v1.1?

e-Ortho Shoulder Software v1.1 is manufactured by FH Industrie.

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.

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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.