FDA.report

510(k) K223348

Device
My3D® Personalized Pelvic Reconstruction
Applicant
Onkos Surgical, Inc.
510(k) number
K223348
Product code
LPH
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-30
Date received
2022-11-02
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Matthew Vernak
Address
77 E. Halsey Rd. Parsippany NJ US 07054 07054

FDA Registration Numbers

Source Documents

510(k) summary PDF

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