FDA.reportPublic FDA data

General

Primary DI
10889981437527
Brand
General
Company
Seaspine Orthopedics Corporation
Model
ST3-000013
Catalog number
ST3-000013
Device description
Universal Lid, 10x10, Orthofix Orange
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211606000Mariner Deformity SystemSeaSpine Orthopedics Corporation2021-06-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981437527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998143752710889981437527

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
10889981080877Malibu91-214791-21472016-05-02
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203708Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203715Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203722Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203739Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203746Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203753Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203760Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203777Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203784Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203791Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203807Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203814Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203821Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203838Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203845Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203852Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203869Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203876Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203883Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203890Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203906Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203913Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203920Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06