FDA 510(k)

OsteoVation Impact

K-Number: K162864 · 2017-01-13

Decision Date2017-01-13

Product CodeGXP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OsteoVation Impact is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Kinetics, LLC. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K162864. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoVation Impact?

OsteoVation Impact is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Skeletal Kinetics, LLC. The 510(k) number is K162864.

When did OsteoVation Impact receive FDA 510(k) clearance?

OsteoVation Impact received FDA 510(k) clearance on 2017-01-13, under 510(k) number K162864.

Who is the listed applicant for OsteoVation Impact?

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

What is the FDA product code for OsteoVation Impact?

The FDA product code for OsteoVation Impact is GXP.

Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, 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.