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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 the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2016-09-27 under 510(k) 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. The listed applicant is Ceremed , Inc.. The 510(k) number is K161446.

When did Biopor Porous Polyethylene Implants receive FDA 510(k) clearance?

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

Who is the listed applicant for Biopor Porous Polyethylene Implants?

The FDA 510(k) record lists Ceremed , Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ceremed , Inc. 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.

K160988Biopor, AOC Porous Polyethylene, Cerepor

Related Devices (Code: GWO)

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.

K261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)Osteonic Co., Ltd.

Official Source

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

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