FDA.reportPublic FDA data

Facet screw

Primary DI
07290019421238
Brand
Facet screw
Company
ZYGOFIX LTD
Model
1
Catalog number
ZF-40FS-20
Device description
The subjected screw 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 and 2) a Modular spacer. The system including a dedicated tool set.
Published
2024-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
07290019421238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019421238072900194212387290019421238

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
532143561
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019421245Facet Screw1ZFS-40SC-252024-10-20
07290019421177zLOCK 1.5mm 3ZF-30MX-152024-09-05
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

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
07290019421245Facet ScrewZYGOFIX LTDMRW2024-10-20
00840916160135SPARTANSPINAL ELEMENTSMRW2020-12-07
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