FDA 510(k)

Biopor, AOC Porous Polyethylene, Cerepor

K-Number: K160988 · 2016-07-14

Decision Date2016-07-14

Product CodeKKY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Biopor, AOC Porous Polyethylene, Cerepor is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160988. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biopor, AOC Porous Polyethylene, Cerepor?

Biopor, AOC Porous Polyethylene, Cerepor is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Ceremed , Inc.. The 510(k) number is K160988.

When did Biopor, AOC Porous Polyethylene, Cerepor receive FDA 510(k) clearance?

Biopor, AOC Porous Polyethylene, Cerepor received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160988.

Who is the listed applicant for Biopor, AOC Porous Polyethylene, Cerepor?

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, AOC Porous Polyethylene, Cerepor?

The FDA product code for Biopor, AOC Porous Polyethylene, Cerepor is KKY.

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.

K161446Biopor Porous Polyethylene Implants

Related Devices (Code: KKY)

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.

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.