Materialise TKA Guide System
K-Number: K251554 · 2025-07-14
ApplicantMaterialise NV
Decision Date2025-07-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Materialise TKA Guide System is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2025-07-14 under approval number K251554. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Materialise TKA Guide System?
Materialise TKA Guide System is a medical device that received FDA 510(k) clearance on 2025-07-14. It is manufactured by Materialise NV. The 510(k) number is K251554.
When was Materialise TKA Guide System approved by the FDA?
Materialise TKA Guide System received FDA 510(k) clearance on 2025-07-14, under approval number K251554.
What company makes Materialise TKA Guide System?
Materialise TKA Guide System is manufactured by Materialise NV.
What is the FDA product code for Materialise TKA Guide System?
The FDA product code for Materialise TKA Guide System is JWH.
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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.