InterSpace GV Hip Spacer— 510(k) K252326

Name: FDA 510(k) clearance K252326
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Substantially Equivalent

Tecres S.P.A.

FDA 510(k) clearance K252326 for InterSpace GV Hip Spacer, Substantially Equivalent on 2025-08-06. Applicant: Tecres S.P.A.. Device class: 2.

Clearance details

Applicant: Tecres S.P.A.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 2025-07-25
Decision date: 2025-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Sommacampagna, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWL

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K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253675 — OsteoRemedies Hip Spacer System2025-12-23
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12
K234028 — COPAL® exchange G hip spacer; COPAL® G+V2024-02-15

More clearances from Tecres S.P.A.

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K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09
K220131 — KYPHON VuE Bone Cement2022-04-18
K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS2019-04-27
K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM2013-03-28
K112983 — SPACER-S2011-12-12

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.