Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)— 510(k) K150064

Name: FDA 510(k) clearance K150064
Creator: U.S. Food and Drug Administration
Published: 2015-09-04

Substantially Equivalent

Orthogem, Ltd.

FDA 510(k) clearance K150064 for Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15), Substantially Equivalent on 2015-09-04. Applicant: Orthogem, Ltd.. Device class: 2.

Clearance details

Applicant: Orthogem, Ltd.
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2015-01-13
Decision date: 2015-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nottingham, GB

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

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.