FDA.reportPublic FDA data

Vu aPOD

Primary DI
10889981160258
Brand
Vu aPOD
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
SR-0295
Catalog number
SR-0295
Device description
Awl Removal Wrench
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981160258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998116025810889981160258

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981137472Shoreline ACS86-001186-00112016-09-30
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
00199150072064Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-05-23
00840493416540LUX Expandable Interbody SystemXENIX MEDICAL LLCHXC2026-03-13
00888867500785Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500808Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500815Arthrex®ARTHREX, INC.HXC2026-03-13
00888867500853Arthrex®ARTHREX, INC.HXC2026-03-13
00199150065974Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2026-02-28
00190376731988IdentiTi IIALPHATEC SPINE, INC.HXC2026-02-18
03662663131636Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131643Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
03662663131650Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2026-02-11
00840180543948General InstrumentsALPHATEC SPINE, INC.HXC2025-12-31
03662663198202Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXC2025-12-17
03662663216760Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663216777Nex-Link OCT Occipital Cervical Plating SystemHighridge Medical, LLCHXC2025-12-17
03662663191906Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-12-16
03662663136549Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136556Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663136563Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663137249Polaris 4.75 Deformity SystemHighridge Medical, LLCHXC2025-11-14
03662663161466The Tether Vertebral Body Tethering SystemHighridge Medical, LLCHXC2025-11-14
03662663192385InCompass Spinal Fixation SystemHighridge Medical, LLCHXC2025-11-14
03662663194129PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXC2025-11-14
00199150051199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXC2025-11-13
00840314269768gSourceGSOURCE LLCHXC2025-08-29
00889797111195Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111201Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111218Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797111225Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26
00889797112642N/AWRIGHT MEDICAL TECHNOLOGY, INC.HXC2025-08-26