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510(k) K173455

SurgTech Bipolar Head System by Surgtech, Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2018
Date Received
November 7, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Surgtech, Inc.

  • K191192 — SurgTech GENOLL Total Knee System (August 1, 2019)
  • K162125 — MALUC™ Total Hip Arthroplasty System (May 10, 2017)
  • K163363 — SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (April 5, 2017)
  • K161894 — SurgTech Trauma System (February 21, 2017)
  • K152200 — SurgTech Interbody System (March 25, 2016)

Other clearances for product code KWY

  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191297 — iNSitu Bipolar Hip System (September 17, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)