FDA.reportPublic FDA data

Mariner Deformity

Primary DI
10889981253899
Brand
Mariner Deformity
Company
Seaspine Orthopedics Corporation
Model
MD1-646600
Catalog number
MD1-646600
Device description
Rod, Straight, ESS+, 6.0mm X 600mm
Published
2024-05-15
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
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
10889981253899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998125389910889981253899

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
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
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
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05