FDA.reportPublic FDA data

Dymaxeon

Primary DI
00815500024636
Brand
Dymaxeon
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
06.6617B-1
Device description
DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø8 x 90mm (YELLOW)
Published
2019-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNBInstrument, Destructive, Fetal, Obstetric
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNBInstrument, Destructive, Fetal, ObstetricObstetrics/Gynecology2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815500024636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500024636008155000246368155000246360815500024636

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-447-5025info@back2basicsdirect.com

Regulatory Flags#

DUNS number
043841348
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815500025268Dymaxeon06.009.06602019-03-12
00815500025275Dymaxeon06.009.06632019-03-12
00815500025343Dymaxeon06.077.20462019-03-12
00815500025350Dymaxeon06.009.07292019-03-12
00815500024278Dymaxeon05.506.6440B-12019-01-30
00815500024285Dymaxeon05.506.6441B-12019-01-30
00815500024292Dymaxeon05.506.6442B-12019-01-30
00815500024308Dymaxeon05.506.6562B-12019-01-30
00815500024315Dymaxeon05.506.6563B-12019-01-30
00815500024322Dymaxeon05.506.6564B-12019-01-30
00815500024339Dymaxeon05.506.6565B-12019-01-30
00815500024346Dymaxeon05.506.6566B-12019-01-30
00815500024353Dymaxeon05.506.6567B-12019-01-30
00815500024360Dymaxeon05.506.6568B-12019-01-30
00815500024377Dymaxeon05.506.6569B-12019-01-31
00815500024384Dymaxeon05.506.6580B-12019-01-31
00815500024391Dymaxeon05.506.6581B-12019-01-31
00815500024407Dymaxeon05.506.6582B-12019-01-31
00815500024414Dymaxeon05.506.6583B-12019-01-31
00815500024421Dymaxeon05.506.6584B-12019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2015-08-05
04546540147257XIA IIStryker CorporationMNI2014-12-08
04546540147257XIA IIStryker CorporationMNH2014-12-08
04546540147769XIA IIStryker CorporationMNH2014-12-08
04546540147769XIA IIStryker CorporationMNI2014-12-08
04546540147806XIA IIStryker CorporationMNH2014-12-08
04546540147806XIA IIStryker CorporationMNI2014-12-08
04546540147905XIA IIStryker CorporationMNH2014-12-08
04546540147905XIA IIStryker CorporationMNI2014-12-08
04546540147912XIA IStryker CorporationMNI2014-12-08
04546540147912XIA IStryker CorporationMNH2014-12-08
04546540147929XIA IStryker CorporationMNH2014-12-08
04546540147929XIA IStryker CorporationMNI2014-12-08
04546540147936XIA IStryker CorporationMNH2014-12-08
04546540147936XIA IStryker CorporationMNI2014-12-08
04546540147974XIA IStryker CorporationMNH2014-12-08
04546540147974XIA IStryker CorporationMNI2014-12-08
04546540147981XIA IStryker CorporationMNI2014-12-08
04546540147981XIA IStryker CorporationMNH2014-12-08
04546540147998XIA IStryker CorporationMNI2014-12-08
04546540147998XIA IStryker CorporationMNH2014-12-08