CERAMENT G— 510(k) K234008

Substantially Equivalent

Bonesupport AB

FDA 510(k) clearance K234008 for CERAMENT G, Substantially Equivalent on 2024-03-13. Applicant: Bonesupport AB. Device class: 2.

Clearance details

Applicant: Bonesupport AB
Product code: Code QRR
Device class: Class 2
Regulation: 21 CFR 888.3046
Advisory panel: Orthopedic
Date received: 2023-12-19
Decision date: 2024-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRR

DEN210044 — CERAMENT G2022-05-17

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K201535 — Cerament Bone Void Filler2020-10-16
K090871 — CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-122009-09-04
K073316 — CERAMENT BONE VOID FILLER, MODEL A02102008-06-20
K051951 — CERAMENT BONE VOID FILLER2005-09-28

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