FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
My3D® Personalized Pelvic Reconstruction
K Number: K212815
·
Decision Jul 6, 2022
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
6
Review Days
306
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Basic Information
- Device Name
- My3D® Personalized Pelvic Reconstruction
- K Number
- K212815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Onkos Surgical
- Date Received
- September 3, 2021
- Decision Date
- July 6, 2022
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Onkos Surgical
| K Number | Device Name | ||
|---|---|---|---|
| DEN210058 | ELEOSx Limb Salvage System | Apr 5, 2024 | Unknown |
| K211677 | ELEOS Limb Salvage System | Jul 28, 2021 | Substantially Equivalent |
| K203815 | ELEOS Limb Salvage System with BioGrip | Jun 9, 2021 | Substantially Equivalent |
| K203588 | ELEOS Limb Salvage System | Feb 5, 2021 | Substantially Equivalent |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Dec 11, 2020 | Substantially Equivalent |