Who else makes this device?

Name: Opus Mg Set BVF
Brand: Opus Mg Set BVF

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Opus Mg Set BVF

Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It…

Registry build 21.09.26

Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.

2manufacturers in China registered for this device type

6catalogue numbers in this listing

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code MQV
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Allgens Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	1

Record

Regulatory record for Opus Mg Set BVF
Listed by	Bone Solutions, Inc., United States
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Repacker / relabeller, Manufacturer
Record published	2021-09-27
Record revised	2026-06-19 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2026-06-18

Catalogue Numbers

Catalogue numbers for Opus Mg Set BVF
Catalogue number	Size	Status
5cc		Withdrawn
15cc		Withdrawn
15cc		Withdrawn
10cc		Withdrawn
10cc		Withdrawn
5cc		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Synthacer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	360
Syntricer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	357
Biosorb	S.B.M	65
MagnetOs	Kuros Biosciences B.V	61
BioSet®	Rti Surgical, Inc.	47
Bicera® Resorbable Bone Substitute	Wiltrom Corporation Limited	41
GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM)	Medtronic Sofamor Danek, Inc.	40
Bicera® Resorbable Bone Substitute	Wiltrom Co., Ltd. (Chutung)	39
ChronOS	Synthes Gmbh	39
Synthacer/Syntricer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	36
Inion BioRestore™	Inion OY	35
Resorba Synthetic Bone	Biomatlante	35

Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K251522	2025-10-13
K242372	2024-10-18
K234013	2024-02-05
K221256	2022-06-28
K212991	2022-01-21
K071004	2009-05-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.