Spacer-G and Spacer-K— 510(k) K101356

Name: FDA 510(k) clearance K101356
Creator: U.S. Food and Drug Administration
Published: 2011-09-20

Substantially Equivalent

Tecres S.P.A.

FDA 510(k) clearance K101356 for Spacer-G and Spacer-K, Substantially Equivalent on 2011-09-20. 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: 2010-05-14
Decision date: 2011-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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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.