FDA.reportPublic FDA data

PCT

Primary DI
00840402511489
Brand
PCT
Company
Silony Medical Corp
Model
PCT0435080
Catalog number
PCT0435080
Device description
3.5mm Pre-Lordosed Rod,80mm
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152211000PCT SystemCentinel Spine, Inc.2015-12-01NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101027241PreviousGS10
00840402511489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101027241008151010272418151010272410815101027241
00840402511489008404025114898404025114890840402511489

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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 designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCNKG2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCNKG2026-06-05
M711BTA2020Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
M711LS7490Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04