FDA.reportPublic FDA data

XEMPLIFI

Primary DI
00889095205916
Brand
XEMPLIFI
Company
GLOBUS MEDICAL, INC.
Model
8103.0208S
Device description
XEMPLIFI DBM Plus, 8cc
Published
2015-10-10
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
MBPFiller, bone void, osteoinduction (w/o human growth factor)
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103036000ALLOFUSE PLUSAllosource, Inc.2011-01-10MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095205916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095205916008890952059168890952059160889095205916

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Milliliter

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710337MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710344MagnetOsKuros Biosciences B.V.MQV2018-01-08