FDA.reportPublic FDA data

Dymaxeon

Primary DI
00815500023974
Brand
Dymaxeon
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
06.6405B-1
Device description
DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø8.0 x 55mm (YELLOW)
Published
2019-01-28
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815500023974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500023974008155000239748155000239740815500023974

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
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-18
18257200054206SFSOrthofix US LLCNKB2026-07-17
18257200054213SFSOrthofix US LLCNKB2026-07-17
18257200054220SFSOrthofix US LLCNKB2026-07-17
18257200054237SFSOrthofix US LLCNKB2026-07-17
18257200054244SFSOrthofix US LLCNKB2026-07-17
18257200054251SFSOrthofix US LLCNKB2026-07-17
18257200054268SFSOrthofix US LLCNKB2026-07-17
18257200054275SFSOrthofix US LLCNKB2026-07-17
18257200054282SFSOrthofix US LLCNKB2026-07-17
18257200054299SFSOrthofix US LLCNKB2026-07-17
18257200054305SFSOrthofix US LLCNKB2026-07-17
18257200054312SFSOrthofix US LLCNKB2026-07-17
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13