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FDA 510(k)

My3D® Personalized Pelvic Reconstruction

K-Number: K223348 · 2023-01-30

ApplicantOnkos Surgical, Inc.
Decision Date2023-01-30
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

My3D® Personalized Pelvic Reconstruction is a medical device manufactured by Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2023-01-30 under approval number K223348. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2023-01-30. It is manufactured by Onkos Surgical, Inc.. The 510(k) number is K223348.

When was My3D® Personalized Pelvic Reconstruction approved by the FDA?

My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2023-01-30, under approval number K223348.

What company makes My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is manufactured by Onkos Surgical, Inc..

What is the FDA product code for My3D® Personalized Pelvic Reconstruction?

The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT07544667 Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration RECRUITING NCT07254351 Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics RECRUITING

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026)

Other Devices by Onkos Surgical, Inc.

K161520ELEOS Limb Salvage System K180130ELEOS™ Bipolar Acetabular System K252920ELEOS™ Limb Salvage System with NanoCept® Technology

Related Devices (Code: LPH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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