My3D® Personalized Pelvic Reconstruction

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Onkos Surgical

The following data is part of a premarket notification filed by Onkos Surgical with the FDA for My3d® Personalized Pelvic Reconstruction.

Pre-market Notification Details

• Device ID: K212815
• 510k Number: K212815
• Device Name: My3D® Personalized Pelvic Reconstruction
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: Onkos Surgical 77 East Halsey Rd. Parsippany, NJ 07054
• Contact: Matthew Vernak
• Correspondent: Matthew Vernak; Onkos Surgical 77 East Halsey Rd. Parsippany, NJ 07054
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-03
• Decision Date: 2022-07-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B278DG6512004N0	K212815	000
B278DGCS02004N0	K212815	000
B278AMM3DMD04N0	K212815	000
B278AMC3DMD04N0	K212815	000
B278DR4320004N0	K212815	000
B278DR4305004N0	K212815	000
B278DR4302504N0	K212815	000
B278PVTRYLD04T0	K212815	000
B278PVTRAY204T0	K212815	000
B278PVTRAY104T0	K212815	000
B278PV65TRY04T0	K212815	000
B278HD35TRQ04N0	K212815	000
B278HDSP03604N0	K212815	000
B278PVACREC04M0	K212815	000
B278DVRGDMD04N0	K212815	000
B278DVFLXMD04N0	K212815	000
B278SF6500004N0	K212815	000
B278HDBP33204N0	K212815	000
B278EX3506504N0	K212815	000
B278TP65180040	K212815	000
B278TP6505004N0	K212815	000
B278TP6502504N0	K212815	000
B278PVGUIDE04N0	K212815	000
B278PVAPRCN04M0	K212815	000
B278AP3801604M0	K212815	000