FDA.reportPublic FDA data

MICROFUSE

Primary DI
00849044044140
Brand
MICROFUSE
Company
GLOBUS MEDICAL, INC.
Model
838.059S
Device description
MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 55mm, Lordotic
Published
2015-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102392000MICROFUSE PUTTY AND MICROFUSE ST MISGlobus Medical, Inc.2010-12-22MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849044044140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849044044140008490440441408490440441400849044044140

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height6.5Millimeter
Length55Millimeter
Width6.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095258516CONCORD4129.2000S2015-11-07
00889095258523CONCORD4129.4000S2015-11-07
00889095343045CONCORD458.693S2015-12-09
00889095358230CONCORD4129.2020S2024-12-01
00889095358247CONCORD4129.4040S2024-12-01
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccSurgentec, LLCMQV2025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccSurgentec, LLCMQV2025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccSurgentec, LLCMQV2025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccSurgentec, LLCMQV2025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccSurgentec, LLCMQV2025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccSurgentec, LLCMQV2025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00850391007245Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007306Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00850391007313Montage Flowable Settable Bone PasteABYRX, INC.MQV2023-11-16
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00813954023915OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2020-09-15
00085412654362ALTAPOREApatech LtdMQV2019-12-11