e-Ortho Shoulder Software
K-Number: K201928 · 2020-09-30
ApplicantFH Industrie
Decision Date2020-09-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
e-Ortho Shoulder Software is a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2020-09-30 under approval number K201928. 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?
e-Ortho Shoulder Software is a medical device that received FDA 510(k) clearance on 2020-09-30. It is manufactured by FH Industrie. The 510(k) number is K201928.
When was e-Ortho Shoulder Software approved by the FDA?
e-Ortho Shoulder Software received FDA 510(k) clearance on 2020-09-30, under approval number K201928.
What company makes e-Ortho Shoulder Software?
e-Ortho Shoulder Software is manufactured by FH Industrie.
What is the FDA product code for e-Ortho Shoulder Software?
The FDA product code for e-Ortho Shoulder Software is LLZ.
Other Devices by FH Industrie
Related Devices (Code: LLZ)
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.