FDA.reportPublic FDA data

Dynesys®

Primary DI
00889024284012
Brand
Dynesys®
Company
Zimmer GmbH
Model
01.03756.455
Device description
DYNESYS HA Pedicle+Set Screw 6.4x55
Published
2015-10-16
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

Contact Domains#

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
00889024284012PrimaryGS10
00889024407039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024284012008890242840128890242840120889024284012
00889024407039008890244070398890244070390889024407039

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
488133448
Device count
2
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024593152Wagner Cone Prosthesis®01.00561.31301.00561.3132022-12-13
00889024593176Wagner Cone Prosthesis®01.00561.21501.00561.2152022-12-13
00889024593183Wagner Cone Prosthesis®01.00561.21601.00561.2162022-12-13
00889024593190Wagner Cone Prosthesis®01.00561.21701.00561.2172022-12-13
00889024593206Wagner Cone Prosthesis®01.00561.31401.00561.3142022-12-13
00889024593213Wagner Cone Prosthesis®01.00561.21801.00561.2182022-12-13
00889024593237Wagner Cone Prosthesis®01.00561.21901.00561.2192022-12-13
00889024593251Wagner Cone Prosthesis®01.00561.31701.00561.3172022-12-13
00889024593268Wagner Cone Prosthesis®01.00561.31801.00561.3182022-12-13
00889024593534Wagner SL Revision®01.00102.62401.00102.6242022-12-13
00889024593541Wagner SL Revision®01.00102.62501.00102.6252022-12-13
00889024593145Wagner Cone Prosthesis®01.00561.21301.00561.2132022-12-13
00889024593169Wagner Cone Prosthesis®01.00561.21401.00561.2142022-12-13
00889024593220Wagner Cone Prosthesis®01.00561.31501.00561.3152022-12-13
00889024593244Wagner Cone Prosthesis®01.00561.31601.00561.3162022-12-13

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
00889024481619Dynesys®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