FDA.reportPublic FDA data

NewPort

Primary DI
10889981083755
Brand
NewPort
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
91-8283
Catalog number
91-8283
Device description
NewPort Cupped Compressor
Published
2016-03-31
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981083755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998108375510889981083755

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. 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
B922F005003608ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWN2026-03-11
G079C5080000140MIS Golden Isles Pedicle Screw System Intelivation, LLCHWN2026-01-30
00199150061983Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2026-01-15
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
00840180543733General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
00840180544037General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-17
00840124525061Metalogix RevolutionFUSION ORTHOPEDICS, LLCHWN2025-12-16
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLCHWN2025-12-16
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03