FDA.reportPublic FDA data

DSS Pedicle screw set, Ø8.0 x 45mm

Primary DI
04260148893940
Brand
DSS Pedicle screw set, Ø8.0 x 45mm
Company
Paradigm Spine, LLC
Model
DPI58045
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04260148893940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148893940042601488939404260148893940

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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260148898235CoFix Implant 8 mmRQI00008RQI000082020-03-19
04260148898242CoFix Implant 10 mmRQI00010RQI000102020-03-19
04260148898259CoFix Implant 12 mmRQI00012RQI000122020-03-19
04260148898266CoFix Implant 14 mmRQI00014RQI000142020-03-19
04260148898273CoFix Implant 16 mmRQI00016RQI000162020-03-19
04260148897931CoFix Sterilization TrayRAC100002020-03-04
04260636670459coflex-F LIS screw inserterRAT202222020-03-04
04260148896927DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI850452015-10-01
04260148897825coflex crimping pliers, longUAT102502018-10-23
04260148897849coflex dual pliersUAT102602018-10-10
04260148894282DSS Pedicle Screw Set, Ø5.0 x 60mmDPI550602018-08-03
04260148894299DSS Pedicle Screw Set, Ø6.0 x 60mmDPI560602018-08-03
04260148894305DSS Pedicle Screw Set, Ø7.0 x 60mmDPI570602018-08-03
04260148897856coflex MalletUAT201202018-08-02
04260148897863coflex mallet capUAT201302018-08-02
04260148897740coflex trial with guide and x-ray marker, 8mmUXT100082018-06-28
04260148897757coflex trial with guide and x-ray marker, 10mmUXT100102018-06-28
04260148897764coflex trial with guide and x-ray marker, 12mmUXT100122018-06-28
04260148897771coflex trial with guide and x-ray marker, 14mmUXT100142018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmUXT100162018-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887087CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
00763000887117CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
00763000887148CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
03662663109871Dynesys Dynamic Stabilization SystemHighridge Medical, LLCNQP2025-11-14
00643169281165CD HORIZON® ASTUTE™ SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK, INC.NQP2024-05-18
00643169281110CD HORIZON® ASTUTE™ SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK, INC.NQP2024-05-02
00763000312985CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000312992CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313036CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313043CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313050CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313081CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313111CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00889024479722Dynesys®Zimmer GmbHNQP2017-07-28
00889024479791Dynesys®Zimmer GmbHNQP2017-07-28
00889024479807Dynesys®Zimmer GmbHNQP2017-07-28
00889024481176Dynesys®Zimmer GmbHNQP2017-07-28
00889024481558Dynesys®Zimmer GmbHNQP2017-07-28
00889024481565Dynesys®Zimmer GmbHNQP2017-07-28
00889024481572Dynesys®Zimmer GmbHNQP2017-07-28
00889024481589Dynesys®Zimmer GmbHNQP2017-07-28
00889024481596Dynesys®Zimmer GmbHNQP2017-07-28
00889024481602Dynesys®Zimmer GmbHNQP2017-07-28
00889024284456Zimmer® DTO®Zimmer GmbHNQP2016-08-29
00889024325340Dynesys®ZIMMER SPINE, INC.NQP2016-06-24
00889024325227Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325234Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325241Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325258Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325265Dynesys®ZIMMER SPINE, INC.NQP2016-06-23