FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
K-Number: K253867 · 2026-01-02
ApplicantZuriMED Technologies AG
Decision Date2026-01-02
Product CodeOWX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is a medical device manufactured by ZuriMED Technologies AG. It received FDA 510(k) clearance on 2026-01-02 under approval number K253867. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is a medical device that received FDA 510(k) clearance on 2026-01-02. It is manufactured by ZuriMED Technologies AG. The 510(k) number is K253867.
When was FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit approved by the FDA?
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit received FDA 510(k) clearance on 2026-01-02, under approval number K253867.
What company makes FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is manufactured by ZuriMED Technologies AG.
What is the FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit?
The FDA product code for FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit is OWX.
Other Devices by ZuriMED Technologies AG
Related Devices (Code: OWX)
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.