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510(k) K223441

SpaceFlex Acetabular Cup by G21, S.R.L. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2023
Date Received
November 14, 2022
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 G21, S.R.L.

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  • K202338 — SpaceFlex Shoulder (February 17, 2021)
  • K201960 — SpaceFlex Knee - 80mm Size (August 13, 2020)
  • K193059 — G1 40 Radiopaque Bone Cement (March 19, 2020)
  • K193061 — G3 40 Radiopaque Bone Cement (March 19, 2020)
  • K192041 — G21 SpaceFlex Hip (October 29, 2019)
  • K190216 — SpaceFlex Knee (June 9, 2019)
  • K181282 — G3A 40 Bone Cement (January 9, 2019)
  • K173494 — OrthoSteady G Bone Cement (March 6, 2018)
  • K152557 — Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (February 23, 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)
  • 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)
  • K183114 — Corin BiPolar-i (June 5, 2019)