MODIFICATION TO CERASORB ORTHO— 510(k) K031651

Name: FDA 510(k) clearance K031651
Creator: U.S. Food and Drug Administration
Published: 2003-08-13

Substantially Equivalent

Curasan AG

FDA 510(k) clearance K031651 for MODIFICATION TO CERASORB ORTHO, Substantially Equivalent on 2003-08-13. Applicant: Curasan AG. Device class: 2.

Clearance details

Applicant: Curasan AG
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2003-05-28
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kleinostheim, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQV

view all

K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETE2026-09-11
K260364 — Device 300419 Strip2026-06-02
K252797 — JAZBI Resorbable Bone Void Filler2026-05-26
K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more2026-04-24
K253524 — Adaptos®Fuse Bone Graft2026-02-17

More clearances from Curasan AG

view all

K181721 — Ceracell Ortho Foam2018-09-17
K160566 — Cerasorb Ortho Foam2016-12-02
K111105 — CURASAN OSSEOLIVE DENTAL2012-12-20
K103709 — CERACELL DENTAL2011-03-10
K102872 — OSBONE DENTAL2011-01-12

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.