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FDA 510(k)

Biopor Porous Polyethylene Implants

K-Number: K161446 · 2016-09-27

ApplicantCeremed , Inc.
Decision Date2016-09-27
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Biopor Porous Polyethylene Implants is a medical device manufactured by Ceremed , Inc.. It received FDA 510(k) clearance on 2016-09-27 under approval number K161446. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biopor Porous Polyethylene Implants?

Biopor Porous Polyethylene Implants is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Ceremed , Inc.. The 510(k) number is K161446.

When was Biopor Porous Polyethylene Implants approved by the FDA?

Biopor Porous Polyethylene Implants received FDA 510(k) clearance on 2016-09-27, under approval number K161446.

What company makes Biopor Porous Polyethylene Implants?

Biopor Porous Polyethylene Implants is manufactured by Ceremed , Inc..

What is the FDA product code for Biopor Porous Polyethylene Implants?

The FDA product code for Biopor Porous Polyethylene Implants is GWO.

Related Clinical Trials

NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING

Other Devices by Ceremed , Inc.

K160988Biopor, AOC Porous Polyethylene, Cerepor

Related Devices (Code: GWO)

K161821Stryker Universal MeshStryker K153248PEEK Customized Cranial ImplantStryker K170725Stryker Universal MeshStryker K170368Sterile NS SystemJeil Medical Corporation K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.

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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