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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 the device name listed in this FDA 510(k) record. The listed applicant is Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) 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. The listed applicant is Oxford Performance Materials, Inc.. The 510(k) number is K161052.

When did OsteoFab Patient Specific Facial Device receive FDA 510(k) clearance?

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

Who is the listed applicant for OsteoFab Patient Specific Facial Device?

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

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

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

Other records listing Oxford Performance Materials, 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.

K190915OsteoFab Suture AnchorsK180064OsteoFab Patient Specific Cranial Device

Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK160988Biopor, AOC Porous Polyethylene, CereporCeremed , 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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