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FDA 510(k), K223538, Integrity Implant
FDA 510(k), K223538, Integrity Implant
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510(K) Number: K223538
Device Name: Integrity Implant
Manufacturer: Wei Zhao
Device Classification Name: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation Number: OWX
Classification Product Code: KXA
Date Received: 11/23/2022
Decision Date: 08/17/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: Integrity Implant
Manufacturer: Wei Zhao
Device Classification Name: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Regulation Number: OWX
Classification Product Code: KXA
Date Received: 11/23/2022
Decision Date: 08/17/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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