FDA.report

Dynesys® Top-Loading System

Primary DI
00889024285484
Brand
Dynesys® Top-Loading System
Company
Zimmer GmbH
Model
01.03957.245
Device description
DTL Cann. HA Pedicle+Set screw 7.2x45
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

Related Records

Contact Domains

Product Codes

CodeName
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications

CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024285484PrimaryGS10
00889024408159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024285484008890242854848890242854840889024285484
00889024408159008890244081598890244081590889024408159

GMDN Terms

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

TypeValueUnit
Length45Millimeter

Sterilization Methods

Method

Contacts

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

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00889024593169Wagner Cone Prosthesis®01.00561.21401.00561.2142022-12-13
00889024593220Wagner Cone Prosthesis®01.00561.31501.00561.3152022-12-13
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00643169281110CD HORIZON® ASTUTE™ SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK, INC.NQP2024-05-02
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00889024479791Dynesys®Zimmer GmbHNQP2017-07-28
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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
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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