FDA.reportPublic FDA data

Mariner

Primary DI
10889981129477
Brand
Mariner
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
90-0305
Catalog number
90-0305
Device description
Set Screw Starter, Axial
Published
2016-09-02
Public version status
Update
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
HWDSTARTER, BONE SCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWDStarter, Bone ScrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981129477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998112947710889981129477

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

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
00841731134752Hintermann Series VILEX LLCHWD2025-09-17
00840019968867Dakota ALIF Plate SystemPRECISION SPINE, INC.HWD2025-03-13
00840180529270General InstrumentsALPHATEC SPINE, INC.HWD2024-08-01
B07315K0140200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
B07315K0160200NIDO Pedicle Screw SystemKalitec Direct LLCHWD2023-10-06
00887868570940Distal Screw SheathBiomet Orthopedics, LLCHWD2023-08-15
00887868570049Distal ScrewBiomet Orthopedics, LLCHWD2023-06-13
00887868570124Lag Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570148Affixus®Biomet Orthopedics, LLCHWD2023-06-13
00887868570155Anti-Rotation Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570162Anti-Rotation Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00887868570179Anti-Rotation Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570186Lag Screw SheathBiomet Orthopedics, LLCHWD2023-06-13
00887868570193Lag Screw SleeveBiomet Orthopedics, LLCHWD2023-06-13
00887868570230Lag Screw TapBiomet Orthopedics, LLCHWD2023-06-13
00887868570247Distal Screw TrocharBiomet Orthopedics, LLCHWD2023-06-13
00844856069756ArsenalALPHATEC SPINE, INC.HWD2023-05-13
00190376477954AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477961AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477978AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00190376477985AMP-LTXALPHATEC SPINE, INC.HWD2023-04-27
00885556864869Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864876Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864883Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864890Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00885556864906Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWD2023-01-19
00816342024310Parcus InstrumentationPARCUS MEDICAL LLCHWD2022-12-06
07640181161522StarterKeri Medical SAHWD2022-11-22
00840180511473General InstrumentALPHATEC SPINE, INC.HWD2022-10-13
03760225710487IBS™IN2BONESHWD2022-05-09