FDA.reportPublic FDA data

Specials

Primary DI
10889981325350
Brand
Specials
Company
Seaspine Orthopedics Corporation
Model
SR-1230
Catalog number
SR-1230
Device description
Shortened Reduction Driver, Tri-Flat
Published
2024-03-06
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173882000SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018-02-06NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981325350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998132535010889981325350

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). 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
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
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
04546540147257XIA IIStryker CorporationNKB2014-12-08
04546540147769XIA IIStryker CorporationNKB2014-12-08
04546540147806XIA IIStryker CorporationNKB2014-12-08
04546540147905XIA IIStryker CorporationNKB2014-12-08
04546540147912XIA IStryker CorporationNKB2014-12-08
04546540147929XIA IStryker CorporationNKB2014-12-08
04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08