FDA.reportPublic FDA data

NorthStar

Primary DI
10889981196622
Brand
NorthStar
Company
Seaspine Orthopedics Corporation
Model
PC1-013502
Catalog number
PC1-013502
Device description
Rod-to-Rod Connector, 3.5mm MD
Published
2025-12-19
Public version status
New
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
K231654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231654000NorthStar OCT SystemSeaspine, Inc.2023-08-03NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981196622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998119662210889981196622

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
079840876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981172374Mariner Outrigger99-000899-00082019-07-26
10889981172466Mariner Outrigger99-001799-00172019-07-26
10889981172695Mariner Outrigger99-1010-1299-1010-122019-07-30
10889981172732Mariner Outrigger99-1012-1299-1012-122019-07-30
10889981172749Mariner Outrigger99-1012-1499-1012-142019-07-30
10889981172800Mariner Outrigger99-1015-1499-1015-142019-07-30
10889981184940Mariner Outrigger99-1023-1299-1023-122019-07-30
10889981125783Newport MIS64-856564-85652025-12-19
10889981125790Newport MIS64-857064-85702025-12-19
10889981125837NewPort64-957064-95702024-12-11
10889981125844NewPort64-958064-95802024-12-11
10889981130060NewPort64-555064-55502024-12-11
10889981130077NewPort64-657564-65752024-12-11
10889981130091NewPort64-853064-85302024-12-11
10889981134921NewPort64-472564-47252024-12-11
10889981134938NewPort64-476064-47602024-12-11
10889981134945NewPort64-475564-47552024-12-11
10889981135348NewPort64-553064-55302024-12-11
10889981135355NewPort64-553564-55352024-12-11
10889981135362NewPort64-554064-55402024-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWP2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWP2026-07-21