FDA.reportPublic FDA data

Hero

Primary DI
00840606104135
Brand
Hero
Company
SPINAL ELEMENTS, INC.
Model
01002-008
Device description
HERO DBM+ PASTE, 8 CC
Published
2015-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606104135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606104135008406061041358406061041350840606104135

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (760) 607 0121info@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
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
08719699710351MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710368MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710375MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710382MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710399MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710405MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710412MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710436MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710443MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710450MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710429MagnetOsKuros Biosciences B.V.MQV2018-01-05
08809204338580TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338597TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338603TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338610TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338627TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338634TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338641TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338658TruForm+Hans Biomed Corp.MQV2017-07-18