Bio2 CLM BG Bioactive Scaffold

Q: What is the product code of K142463?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.

FDA 510(k) K142463 · Bio2 Technologies, Inc.

Substantially Equivalent

510(k) numberK142463

Submission

Device name: Bio2 CLM BG Bioactive Scaffold
Applicant: Bio2 Technologies, Inc.
Woburn, MA, US
Received: September 2, 2014
Decision date: December 18, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MQV – Filler, Bone Void, Calcium Compound
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3045
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code MQV

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K262230	Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional	Bone Solutions, Inc.	09/11/2026SE
K260364	Device 300419 StripMQV · Traditional	Geistlich Pharma AG	06/02/2026SE
K252797	JAZBI Resorbable Bone Void FillerMQV · Traditional	Sdip Innovations Pty, Ltd.	05/26/2026SE
K261008	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special	Stryker Spine	04/24/2026SE
K253524	Adaptos®Fuse Bone GraftMQV · Traditional	Biomendex OY	02/17/2026SE
K253147	FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special	Prosidyan, Inc.	10/22/2025SE
K251522	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional	Bone Solutions, Inc.	10/13/2025SE
K252085	Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional	Wright Medical Technology, Inc. (Stryker…	09/30/2025SE
K251556	Device 300423 GranulesMQV · Traditional	Geistlich Pharma AG	07/17/2025SE
K251720	OsteoFlo HydroFiberMQV · Special	SurGenTec, LLC	07/02/2025SE

More from SurGenTec, LLC

510(k)	Device	Decision
K152589	Bio2 CLM BG Bioactive ScaffoldMQV · Traditional	01/12/2016SE
K151876	Bio2 Fusion Implant SystemHTY · Traditional	12/30/2015SE

Questions and answers

When was Bio2 CLM BG Bioactive Scaffold cleared by the FDA?

Bio2 CLM BG Bioactive Scaffold (K142463) received a 510(k) decision of Substantially Equivalent on December 18, 2014, 107 days after the submission was received.

What is the product code of K142463?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.