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FDA 510(k)

OsteoFab Patient Specific Facial Device

K-Number: K161052 · 2016-07-20

ApplicantOxford Performance Materials, Inc.
Decision Date2016-07-20
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OsteoFab Patient Specific Facial Device is a medical device manufactured by Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2016-07-20 under approval number K161052. 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 OsteoFab Patient Specific Facial Device?

OsteoFab Patient Specific Facial Device is a medical device that received FDA 510(k) clearance on 2016-07-20. It is manufactured by Oxford Performance Materials, Inc.. The 510(k) number is K161052.

When was OsteoFab Patient Specific Facial Device approved by the FDA?

OsteoFab Patient Specific Facial Device received FDA 510(k) clearance on 2016-07-20, under approval number K161052.

What company makes OsteoFab Patient Specific Facial Device?

OsteoFab Patient Specific Facial Device is manufactured by Oxford Performance Materials, Inc..

What is the FDA product code for OsteoFab Patient Specific Facial Device?

The FDA product code for OsteoFab Patient Specific Facial Device is KKY.

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Other Devices by Oxford Performance Materials, Inc.

K180064OsteoFab Patient Specific Cranial Device K190915OsteoFab Suture Anchors

Related Devices (Code: KKY)

K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc. K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC

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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