Normatec Elite Hip— 510(k) K251905

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K251905 for Normatec Elite Hip, Substantially Equivalent on 2025-09-18. Applicant: NormaTec Industries, LP.

Clearance details

Applicant: NormaTec Industries, LP
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2025-06-20
Decision date: 2025-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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