Normatec Elite Hip
K-Number: K251905 · 2025-09-18
Device Summary
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. The listed applicant is NormaTec Industries, LP. The 510(k) number is K251905.
When did Normatec Elite Hip receive FDA 510(k) clearance?
Normatec Elite Hip received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251905.
Who is the listed applicant for Normatec Elite Hip?
The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Normatec Elite Hip?
The FDA product code for Normatec Elite Hip is IRP.
Other records listing NormaTec Industries, LP 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.
Related Devices (Code: IRP)
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.
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.