FDA.reportPublic FDA data

zLOCK 1.5mm

Primary DI
07290019421177
Brand
zLOCK 1.5mm
Company
ZYGOFIX LTD
Model
3
Catalog number
ZF-30MX-15
Device description
The subjected Spacer of 1.5 mm is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components:1) a Facet Screw with a washer and2) a Modular spacer.The system including a dedicated tool set.
Published
2024-09-05
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

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240085000zLOCK Lumbar Facet Fixation SystemZygofix , Ltd.2024-04-18MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019421177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019421177072900194211777290019421177

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 millibar1013 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532143561
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019421184zLOCK 2.0mm 3ZF-30MX-202024-09-05
07290019421191zLOCK 2.5mm 3ZF-30MX-252024-09-05
07290019421207zLOCK 3.0mm 3ZF-30MX-302024-09-05
07290019421214zLOCK 3.5mm 3ZF-30MX-352024-09-05
07290019421221zLOCK 4.0mm 3ZF-30MX-402024-09-05
07290019421122zLOCK tools Tray #11ZFT-1002024-10-20
07290019421139zLOCK tools Tray #2 1ZFT-1002024-10-20
07290019421146zLOCK tools Tray #3 12024-10-20
07290019421153zLOCK tools Trays #1+ #2 1ZFT-1002024-10-20
07290019421160zLOCK tools Trays #1+ #3 1ZFT-1002024-10-20
07290019421245Facet Screw1ZFS-40SC-25TU2024-10-20
07290019421238Facet screw 1ZF-40FS-20TU2024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131885045ION Non CervicalSurgentec, LLCMRW2026-07-28
00810131882761Facet Sterile Implant - 55Surgentec, LLCMRW2026-07-06
00810131882808Facet Sterile Instrument Kit - CervicalSurgentec, LLCMRW2026-07-06
00810131884772ION-C Final KitSurgentec, LLCMRW2026-07-06
00810131884895ION-C ReusableSurgentec, LLCMRW2026-07-06
00810131881795ION Disposable Instrument KitSurgentec, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSurgentec, LLCMRW2026-03-09
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