Home / 510(k) Clearances / K252326

510(k) K252326

InterSpace GV Hip Spacer by Tecres S.P.A. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2025
Date Received
July 25, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Tecres S.P.A.

  • K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV (January 9, 2023)
  • K220131 — KYPHON VuE Bone Cement (April 18, 2022)
  • K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS (April 27, 2019)
  • K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (March 28, 2013)
  • K112983 — SPACER-S (December 12, 2011)
  • K101356 — Spacer-G and Spacer-K (September 20, 2011)
  • K092773 — CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (November 24, 2009)
  • K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221 (May 22, 2008)
  • K062273 — SPACER-G TEMPORARY HIP PROSTHESIS (May 22, 2008)
  • K063438 — VSPSPN (January 17, 2007)

Other clearances for product code KWL

  • K253675 — OsteoRemedies Hip Spacer System (December 23, 2025)
  • K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (June 12, 2025)
  • K234028 — COPAL® exchange G hip spacer; COPAL® G+V (February 15, 2024)
  • K222632 — UHR Bipolar Implants, Restoration GAP II Implants (October 21, 2022)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
  • K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (August 29, 2018)
  • K173967 — Remedy Acetabular Cup (February 22, 2018)
  • K143184 — Evolve UniPolar Head (March 17, 2015)
  • K112470 — 2GC HIP/KNEE MODULAR SPACER (April 5, 2012)