FDA.reportPublic FDA data

Dynesys®

Primary DI
00889024481701
Brand
Dynesys®
Company
Zimmer GmbH
Model
01.03957.235
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00889024481701PrimaryGS10
00889024408135Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024481701008890244817018890244817010889024481701
00889024408135008890244081358890244081350889024408135

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
Length35Millimeter
Outer Diameter7.2Millimeter

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
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
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00613994188571CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18