FDA.reportPublic FDA data

Z-Pedicle Screw

Primary DI
04057217000022
Brand
Z-Pedicle Screw
Company
Z-Medical GmbH + Co. KG
Model
A06 052
Published
2024-04-01
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057217000022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057217000022040572170000224057217000022

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497426945540info@z-medical.de

Regulatory Flags#

DUNS number
332068761
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057217006079RodbenderA16 3812024-04-01
04057217001067NAA06051_US2015-06-10
04057217001074NAA06052_US2015-06-10
04057217001081NAA06053_US2015-06-10
04057217001098NAA06054_US2015-06-10
04057217001104NAA06061_US2015-06-10
04057217001111NAA06062_US2015-06-10
04057217001128NAA06063_US2015-06-10
04057217001135NAA06064_US2015-06-10
04057217001142NAA06065_US2015-06-10
04057217001159NAA06071_US2015-06-10
04057217001166NAA06072_US2015-06-10
04057217001173NAA06073_US2015-06-10
04057217001180NAA06074_US2015-06-10
04057217001197NAA06075_US2015-06-10
04057217001203NAA06091_US2015-06-10
04057217001210NAA06092_US2015-06-10
04057217001227NAA06093_US2015-06-10
04057217001234NAA06094_US2015-06-10
04057217001241NAA06095_US2015-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005337NewportSeaspine Orthopedics CorporationNKB2015-09-24