Normatec Elite Hip
K-Number: K251905 · 2025-09-18
ApplicantNormaTec Industries, LP
Decision Date2025-09-18
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Normatec Elite Hip is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2025-09-18 under approval number K251905. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Normatec Elite Hip?
Normatec Elite Hip is a medical device that received FDA 510(k) clearance on 2025-09-18. It is manufactured by NormaTec Industries, LP. The 510(k) number is K251905.
When was Normatec Elite Hip approved by the FDA?
Normatec Elite Hip received FDA 510(k) clearance on 2025-09-18, under approval number K251905.
What company makes Normatec Elite Hip?
Normatec Elite Hip is manufactured by NormaTec Industries, LP.
What is the FDA product code for Normatec Elite Hip?
The FDA product code for Normatec Elite Hip is IRP.
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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.