Who else makes this device?

Name: Microfuse
Brand: Microfuse

Microfuse · Filler, Bone Void, Calcium Compound → Orthopedic

2manufacturers in China registered for this device type

27catalogue numbers in this listing

7510(k) clearances naming this product code

1recall

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 Microfuse
Listed by	Globus Medical, Inc., United States
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Manufacturer, Exporter
510(k)	K102392
Record published	2015-11-08
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date
Sizes	Width 6.5 to 14 mm; height 5 to 12 mm; length 12 to 75 mm; total volume 2.5 to 20 ml

Catalogue Numbers

Catalogue numbers for Microfuse
Catalogue number	Size	Status
838.047S	Width 6.5 mm	In distribution
838.015S	Height 9 mm	In distribution
838.014S	Width 14 mm	In distribution
838.017S	Lordosis 7 Degree	In distribution
838.020S	Total Volume 20 ml	In distribution
838.202S	Total Volume 2.5 ml	In distribution
838.043S	Width 6.5 mm	In distribution
838.002S	Total Volume 2.5 ml	In distribution
838.134S	Width 14 mm	In distribution
838.059S	Height 6.5 mm	In distribution
838.137S	Length 12 mm	In distribution
838.013S	Length 12 mm	In distribution
838.133S	Length 12 mm	In distribution
838.135S	Height 8 mm	In distribution
838.010S	Total Volume 10 ml	In distribution
838.018S	Length 12 mm	In distribution
838.210S	Total Volume 10 ml	In distribution
838.132S	Width 14 mm	In distribution
838.012S	Width 14 mm	In distribution
838.063S	Width 6.5 mm	In distribution
838.138S	Height 11 mm	In distribution
838.016S	Lordosis 7 Degree	In distribution
838.139S	Width 14 mm	In distribution
838.205S	Total Volume 5 ml	In distribution
838.136S	Width 14 mm	In distribution
838.011S	Lordosis 7 Degree	In distribution
838.005S	Total Volume 5 ml	In distribution

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
K133678	2014-08-26
K130977	2013-12-24
K130392	2013-08-15
K102392	2010-12-22
K083232	2008-12-24
K082442	2008-10-07
K071187	2007-12-20

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Microfuse
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Globus Medical, Inc.	510(k) number	2013-08-28	Class II	Process control	The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.	193	2014-11-14

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.

Microfuse