BioSphere MIS Putty (BioSphere MIS)— 510(k) K173301

Name: FDA 510(k) clearance K173301
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Substantially Equivalent

Synergy Biomedical, LLC

FDA 510(k) clearance K173301 for BioSphere MIS Putty (BioSphere MIS), Substantially Equivalent on 2018-01-19. Applicant: Synergy Biomedical, LLC. Device class: 2.

Clearance details

Applicant: Synergy Biomedical, LLC
Product code: Code MQV
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2017-10-17
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Collegeville, PA, US

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 Synergy Biomedical, LLC

view all

K122868 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY2013-04-19

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.