FDA.reportPublic FDA data

Specials

Primary DI
10889981153212
Brand
Specials
Company
Seaspine Orthopedics Corporation
Model
SR0144-1424
Catalog number
SR0144-1424
Device description
Prime NM 31x24mm ALL-IN-ONE TRIAL 16mm 20Deg
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981153212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998115321210889981153212

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
Premarket exempt
true
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
10886982350596VOLTSynthes GmbHHWT2026-09-25
10886982350602VOLTSynthes GmbHHWT2026-09-25
10886982350619VOLTSynthes GmbHHWT2026-09-25
10886982350626VOLTSynthes GmbHHWT2026-09-25
10886982350695VOLTSynthes GmbHHWT2026-09-25
10886982350701VOLTSynthes GmbHHWT2026-09-25
10886982350718VOLTSynthes GmbHHWT2026-09-25
00840606191326PrimusSPINAL ELEMENTS, INC.HWT2026-09-22
03701313009502K-RODS.M.A.I.OHWT2026-09-22
10888857298590ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298606ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298613ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298620ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298637ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298644ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298651ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298668ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298675ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298682ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298699ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298705ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298712ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857298729ALEUTIAN® Interbody SystemsVB Spine LLCHWT2024-05-16
10888857562332K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562349K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562356K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562363K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562370K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562387K2M General InstrumentsVB Spine LLCHWT2023-09-08
10888857562394K2M General InstrumentsVB Spine LLCHWT2023-09-08