Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PK High Tibial Osteotomy Correction System

K-Number: K182285 · 2019-06-20

ApplicantPaonan Biotech Co., Ltd.
Decision Date2019-06-20
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PK High Tibial Osteotomy Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K182285. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PK High Tibial Osteotomy Correction System?

PK High Tibial Osteotomy Correction System is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Paonan Biotech Co., Ltd.. The 510(k) number is K182285.

When did PK High Tibial Osteotomy Correction System receive FDA 510(k) clearance?

PK High Tibial Osteotomy Correction System received FDA 510(k) clearance on 2019-06-20, under 510(k) number K182285.

Who is the listed applicant for PK High Tibial Osteotomy Correction System?

The FDA 510(k) record lists Paonan Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PK High Tibial Osteotomy Correction System?

The FDA product code for PK High Tibial Osteotomy Correction System is KTW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04666571Personalised Against Standard High Tibial OsteotomyCOMPLETED

Other records listing Paonan Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220261NEST-C Interbody SystemK180230NEST Interbody SystemK180228II-Type Intervertebral SpacerK180226TREND II Spinal Fixation System- STEP SeriesK161225Paonan Armstrong Posterior Spinal Fixation System

Related Devices (Code: KTW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.

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.

↑