Bio2 CLM BG Bioactive Scaffold
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152589 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bio2 CLM BG Bioactive Scaffold is a synthetic, non-collagenous, osteoconductive bone void filler. It is designed to be implanted into skeletal voids in the extremities or pelvis, where the material allows for tissue infiltration between its bioactive glass fibers.
This device is provided as sterile cylinders, blocks, or wedges and complies with the requirements of ASTM F-1538. It received FDA 510(k) clearance under K152589 on January 12, 2016. In vitro testing confirms the formation of a hydroxyapatite layer on the surface of the implant when immersed in simulated body fluid.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bio2 CLM BG Bioactive Scaffold (K152589) — FDA 510 (k) | Innolitics, Bio2 CLM BG Bioactive Scaffold — FDA 510 (k) K152589 | MedTracker, PDF Bio2 Technologies, Inc. Janet Krevolin, Ph.D. Chief Technical Officer ..., Bio2 CLM BG Bioactive Scaffold - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152589 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio2 Technologies, Inc.
Sources (1)
- FDA 510(k) K152589 24 fields · synced Sep 23, 2026