My3D Personalized Pelvic Reconstruction
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212815 FDA 510(k)
- FDA Product Code
- LPH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3358 FDA 510(k)
- Regulation Number
- 888.3358 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The My3D Personalized Pelvic Reconstruction is a medical device designed for pelvic reconstruction procedures. It is a personalized implant system that is customized to fit the specific anatomical needs of each patient.
This device is supplied as a sterile, single-use implant and is not intended for reuse. It is available in various sizes to accommodate different patient anatomies. The My3D Personalized Pelvic Reconstruction has received FDA 510(k) clearance with the product code LPH.
Frequently asked questions
What is the My3D Personalized Pelvic Reconstruction used for?
The My3D Personalized Pelvic Reconstruction is a medical device designed specifically for pelvic reconstruction procedures. It is customized to fit the unique anatomical requirements of each patient undergoing such surgery.
How is the My3D implant supplied and can it be reused?
The My3D Personalized Pelvic Reconstruction is supplied as a sterile, single-use implant. It is not intended for reuse and should be discarded after a single surgical procedure to ensure patient safety and device integrity.
What sizes are available for the My3D Pelvic Reconstruction implant?
The My3D Personalized Pelvic Reconstruction is available in various sizes to accommodate different patient anatomies. This range of sizing options allows surgeons to select the most appropriate implant for each individual patient's specific needs.
What regulatory clearance has the My3D Pelvic Reconstruction received?
The My3D Personalized Pelvic Reconstruction has received FDA 510(k) clearance with the product code LPH. This clearance indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212815 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Onkos Surgical
Sources (1)
- FDA 510(k) K212815 24 fields · synced Sep 21, 2026