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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 a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-20 under approval 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. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K182285.

When was PK High Tibial Osteotomy Correction System approved by the FDA?

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

What company makes PK High Tibial Osteotomy Correction System?

PK High Tibial Osteotomy Correction System is manufactured by Paonan Biotech Co., Ltd..

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.

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Other Devices by Paonan Biotech Co., Ltd.

K161225Paonan Armstrong Posterior Spinal Fixation System K180226TREND II Spinal Fixation System- STEP Series K180230NEST Interbody System K180228II-Type Intervertebral Spacer K220261NEST-C Interbody System

Related Devices (Code: KTW)

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

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