FDA.reportPublic FDA data

PCT

Primary DI
00840402512349
Brand
PCT
Company
Silony Medical Corp
Model
PCT06ST004
Catalog number
PCT06ST004
Device description
Straight Hook, 4mm
Published
2025-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101026114PreviousGS10
00840402512349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101026114008151010261148151010261140815101026114
00840402512349008404025123498404025123490840402512349

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
106081213
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840402508342PCTPCT0135010PCT01350102025-11-24
00840402508366PCTPCT0135012PCT01350122025-11-24
00840402508465PCTPCT0135022PCT01350222025-11-24
00840402508502PCTPCT0135026PCT01350262025-11-24
00840402508526PCTPCT0135028PCT01350282025-11-24
00840402508779PCTPCT0140012PCT01400122025-11-24
00840402508793PCTPCT0140014PCT01400142025-11-24
00840402508816PCTPCT0140016PCT01400162025-11-24
00840402508854PCTPCT0140020PCT01400202025-11-24
00840402508878PCTPCT0140022PCT01400222025-11-24
00840402508892PCTPCT0140024PCT01400242025-11-24
00840402508915PCTPCT0140026PCT01400262025-11-24
00840402509301PCTPCT0145024PCT01450242025-11-24
00840402509349PCTPCT0145028PCT01450282025-11-24
00840402509592PCTPCT0235022PCT02350222025-11-24
00840402509615PCTPCT0235024PCT02350242025-11-24
00840402509639PCTPCT0235026PCT02350262025-11-24
00840402509653PCTPCT0235028PCT02350282025-11-24
00840402509677PCTPCT0235030PCT02350302025-11-24
00840402509691PCTPCT0235032PCT02350322025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157082130ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082147ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082154ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082161ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082178ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082192ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082215ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082222ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082239ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082253ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082260ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082284ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082314ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082321ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082338ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082345ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082352ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082369ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082376ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082383ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082390ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082406ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082413ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23