FDA.reportPublic FDA data

Dymaxeon

Primary DI
00815500025619
Brand
Dymaxeon
Company
BACK 2 BASIC DIRECT, LLC
Model
06.0
Catalog number
77.2068
Device description
Screw inserter
Published
2019-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121786000DYMAXEON SPINE SYSTEMB2b Spine Pty, Ltd.2012-11-05NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815500025619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500025619008155000256198155000256190815500025619

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05