FDA.reportPublic FDA data

PCT

Primary DI
00815101026688
Brand
PCT
Company
Centinel Spine, LLC
Model
PCT0335240
Published
2017-02-06
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
00815101026688PrimaryGS10
00840402510925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101026688008151010266888151010266880815101026688
00840402510925008404025109258404025109250840402510925

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
949024850
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193111708Prodisc LPDL-L-PT10S2018-10-16
00843193111715Prodisc LPDL-L-PT12S2018-10-16
00843193111722Prodisc LPDL-L-PT14S2018-10-16
00843193111739Prodisc LPDL-L-SP06S2018-10-16
00843193111746Prodisc LPDL-L-SP11S2018-10-16
00843193111753Prodisc LPDL-M-IP00S2018-10-16
00843193111760Prodisc LPDL-M-PT10S2018-10-16
00843193111777Prodisc LPDL-M-PT12S2018-10-16
00843193111784Prodisc LPDL-M-PT14S2018-10-16
00843193111791Prodisc LPDL-M-SP06S2018-10-16
00843193111807Prodisc LPDL-M-SP11S2018-10-16
00843193112750Prodisc C09.820.025S2018-10-16
00843193112767Prodisc C09.820.026S2018-10-16
00843193112774Prodisc C09.820.027S2018-10-16
00843193112781Prodisc C09.820.035S2018-10-16
00843193112798Prodisc C09.820.036S2018-10-16
00843193112804Prodisc C09.820.037S2018-10-16
00843193112811Prodisc C09.820.045S2018-10-16
00843193112828Prodisc C09.820.046S2018-10-16
00843193112835Prodisc C09.820.047S2018-10-16

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