FDA.reportPublic FDA data

DSS HP Polyaxial pedicle screw set, Ø5 x 45mm

Primary DI
00426014889692
Brand
DSS HP Polyaxial pedicle screw set, Ø5 x 45mm
Company
Paradigm Spine, LLC
Model
HPI85045
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NQPPosterior Metal/Polymer Spinal System, Fusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00426014889692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00426014889692004260148896924260148896920426014889692

GMDN Terms#

Term, Definition table
TermDefinition
Spinal dynamic-stabilization systemA sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787874960
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-07-30
20763000313344CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-17
20613994170174CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2016-07-08
00613994123732CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123749CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123800CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123824CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123831CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123909CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123916CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123923CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123985CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123992CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124012CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124074CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994188540CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197382CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197412CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197344CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197375CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197719CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197788CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197795CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197726CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994197757CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994177193CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188502CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188519CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188533CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18