FDA.reportPublic FDA data

Dynesys®

Primary DI
00889024325418
Brand
Dynesys®
Company
ZIMMER SPINE, INC.
Model
07.01299.001
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00889024325418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024325418008890243254188890243254180889024325418

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle15degree

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
787663400
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024333499Minit®300-4018300-40182015-09-24
00889024334977Sequoia®3306-55503306-55502015-09-24
00889024335004Sequoia®3306-65303306-65302015-09-24
00889024335059Sequoia®3306-65553306-65552015-09-24
00889024335134Sequoia®3306-75603306-75602015-09-24
00889024335165Sequoia®3306-85403306-85402015-09-24
00889024335486Sequoia®3361-0553361-0552016-06-23
00889024331419InFix® Anterior Lumbar System1850-51121850-51122016-06-23
00889024331426InFix® Anterior Lumbar System1850-51141850-51142016-06-23
00889024331433InFix® Anterior Lumbar System1850-53081850-53082016-06-23
00889024331440InFix® Anterior Lumbar System1850-53141850-53142016-06-23
00889024331457InFix® Anterior Lumbar System1850-55081850-55082016-06-23
00889024331464InFix® Anterior Lumbar System1850-55121850-55122016-06-23
00889024402577InFix® Anterior Lumbar System1850-51001850-51002016-06-23
00889024402584InFix® Anterior Lumbar System1850-51081850-51082016-06-23
00889024402591InFix® Anterior Lumbar System1850-51101850-51102016-06-23
00889024402607InFix® Anterior Lumbar System1850-53101850-53102016-06-23
00889024402614InFix® Anterior Lumbar System1850-53121850-53122016-06-23
00889024402621InFix® Anterior Lumbar System1850-55101850-55102016-06-23
00889024402638InFix® Anterior Lumbar System1850-55141850-55142016-06-23

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