FDA.reportPublic FDA data

Specials

Primary DI
10889981326012
Brand
Specials
Company
Seaspine Orthopedics Corporation
Model
SR-1183-20
Catalog number
SR-1183-20
Device description
Sleeve, MIS Locking Navigation Driver
Published
2024-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191648000Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2019-07-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981326012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998132601210889981326012

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28