FDA.reportPublic FDA data

PCT

Primary DI
00840402512615
Brand
PCT
Company
Silony Medical Corp
Model
PCT08FC022
Catalog number
PCT08FC022
Device description
Fixed Cross Connector, 22mm
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
00815101028002PreviousGS10
00840402512615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101028002008151010280028151010280020815101028002
00840402512615008404025126158404025126150840402512615

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
00840019978156Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978163Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978170Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978187Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978194Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978200Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978217Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978224Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978231Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978248Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978255Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978262Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978279Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978286Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978293Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978309Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978316Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978323Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978330Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978347Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978354Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978361Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978378Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978385Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978392Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978408Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978415Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978422Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978439Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978446Reform TiPRECISION SPINE, INC.KWP2026-10-19