FDA.reportPublic FDA data

Vu a-POD Prime NanoMetalene

Primary DI
10889981139476
Brand
Vu a-POD Prime NanoMetalene
Company
Seaspine Orthopedics Corporation
Model
35-97-1420
Catalog number
35-97-1420
Device description
Prime NM Implant, 39x27mm x 14mm, 20 Deg
Published
2016-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162351000SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation2016-12-01OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981139476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998113947610889981139476

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079840876
Device count
1
Lot or batch
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
07613153046196AVS PLStryker CorporationOVD2015-09-14
07613153046226AVS PLStryker CorporationOVD2015-09-14
07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046431AVS TLStryker CorporationOVD2015-09-14
07613153046448AVS TLStryker CorporationOVD2015-09-14
07613153046455AVS TLStryker CorporationOVD2015-09-14
07613153046516AVS TLStryker CorporationOVD2015-09-14
07613153046523AVS TLStryker CorporationOVD2015-09-14
07613153046554AVS TLStryker CorporationOVD2015-09-14
07613153046561AVS TLStryker CorporationOVD2015-09-14
07613153046578AVS TLStryker CorporationOVD2015-09-14
07613153046585AVS TLStryker CorporationOVD2015-09-14
07613153046592AVS TLStryker CorporationOVD2015-09-14
07613153046608AVS TLStryker CorporationOVD2015-09-14
07613153046615AVS TLStryker CorporationOVD2015-09-14
07613153046622AVS TLStryker CorporationOVD2015-09-14
07613153046639AVS TLStryker CorporationOVD2015-09-14
07613153046646AVS TLStryker CorporationOVD2015-09-14
07613153046653AVS TLStryker CorporationOVD2015-09-14
07613153046660AVS TLStryker CorporationOVD2015-09-14
07613153046677AVS TLStryker CorporationOVD2015-09-14
07613153046691AVS TLStryker CorporationOVD2015-09-14