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FDA 510(k)

SurgTech Bipolar Head System

K-Number: K173455 · 2018-06-14

ApplicantSurgtech, Inc.
Decision Date2018-06-14
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech Bipolar Head System is the device name listed in this FDA 510(k) record. The listed applicant is Surgtech, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K173455. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgTech Bipolar Head System?

SurgTech Bipolar Head System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Surgtech, Inc.. The 510(k) number is K173455.

When did SurgTech Bipolar Head System receive FDA 510(k) clearance?

SurgTech Bipolar Head System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K173455.

Who is the listed applicant for SurgTech Bipolar Head System?

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

What is the FDA product code for SurgTech Bipolar Head System?

The FDA product code for SurgTech Bipolar Head System is KWY.

Other records listing Surgtech, 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.

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Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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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