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FDA 510(k), K212815, My3D® Personalized Pelvic Reconstruction
FDA 510(k), K212815, My3D® Personalized Pelvic Reconstruction
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$149.00 USD
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510(K) Number: K212815
Device Name: My3D® Personalized Pelvic Reconstruction
Manufacturer: Onkos Surgical
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 09/03/2021
Decision Date: 07/06/2022
Regulation Medical Specialty: Orthopedic
Device Name: My3D® Personalized Pelvic Reconstruction
Manufacturer: Onkos Surgical
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation Number: 888.3358
Classification Product Code: LPH
Date Received: 09/03/2021
Decision Date: 07/06/2022
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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