FDA.reportPublic FDA data

NewPort™

Primary DI
10889981028220
Brand
NewPort™
Company
Seaspine Orthopedics Corporation
Model
NWPRIMP
Catalog number
NWPRIMP
Device description
NewPort Rod Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Published
2015-09-24
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
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052170000SEASPINE VBR SYSTEMSeaspine, Inc.2005-12-21MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981028220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998102822010889981028220

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

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
Kit
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
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217676CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19