FDA.report

Dymaxeon®

Primary DI
00815500021932
Brand
Dymaxeon®
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
06.6422B
Device description
DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS SCREW Ø6.5X55mm (GREEN)
Published
2016-01-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815500021932PrimaryGS10
10815500021939Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500021932008155000219328155000219320815500021932
1081550002193910815500021939

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length55Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00devices kept at room temperature or other standard conditions
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(216)447-5025info@back2basicsdirect.com

Regulatory Flags

DUNS number
043841348
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00815500023318Dymaxeon5.506.6540B-12020-03-06
00815500023325Dymaxeon5.506.6541B-12020-03-06
00815500023691Dymaxeon5.546.0725-042020-03-06
00815500023479Dymaxeon05.509.06752019-03-12
00815500025374Dymaxeon05.546.42402019-03-07
00815500025381Dymaxeon05.546.42412019-03-07
00815500025398Dymaxeon05.546.42422019-03-07
00815500025404Dymaxeon05.546.42432019-03-07
00815500025411Dymaxeon05.546.42442019-03-07
00815500025428Dymaxeon05.546.42452019-03-12
00815500025435Dymaxeon05.546.42462019-03-12
00815500025442Dymaxeon05.546.42472019-03-12
00815500020010Dymaxeon®05.506.1201B2016-01-19
00815500020027Dymaxeon®05.506.1202B2016-01-19
00815500023585Dymaxeon06.009.07112019-03-07
00815500023592Dymaxeon06.009.07122019-03-07
00815500023608Dymaxeon06.009.07132019-03-07
00815500025572Dymaxeon06.009.06732019-03-25

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