ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC— 510(k) K061880

Name: FDA 510(k) clearance K061880
Creator: U.S. Food and Drug Administration
Published: 2007-08-15

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K061880 for ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC, Substantially Equivalent on 2007-08-15. Applicant: Isotis NV. Device class: 2.

Clearance details

Applicant: Isotis NV
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2006-07-03
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bilthoven, NL

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 Isotis NV

view all

K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY2006-03-29
K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY2006-03-27
K031813 — OSSATURA DENTAL2004-08-20
K041344 — OPEN BORE SYRINGE2004-07-16
K030131 — OSSATURA BCP BONE VOID FILLER2003-05-20

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.