FDA.reportPublic FDA data

LOSPA IS Spinal Fixation System

Primary DI
08806373893803
Brand
LOSPA IS Spinal Fixation System
Company
Corentec Co., Ltd
Model
SI.0P0.0010
Device description
Spinal Instrument - In - situ Bender Right
Published
2020-03-27
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
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373893803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373893803088063738938038806373893803

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82414107176sungwon.yang@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017271088BENCOXHA.02F.00012026-05-06
08800017261294EXULT Knee Replacement SystemK3.IAN.4266-09T2020-01-10
08800017261300EXULT Knee Replacement SystemK3.IAN.4266-10T2020-01-10
08800017261317EXULT Knee Replacement SystemK3.IAN.4266-11T2020-01-10
08800017261324EXULT Knee Replacement SystemK3.IAN.4266-12T2020-01-10
08800017261331EXULT Knee Replacement SystemK3.IAN.4266-13T2020-01-10
08800017261348EXULT Knee Replacement SystemK3.IAN.4266-14T2020-01-10
08800017261355EXULT Knee Replacement SystemK3.IAN.4266-16T2020-01-10
08800017261362EXULT Knee Replacement SystemK3.IAN.4266-18T2020-01-10
08800017261379EXULT Knee Replacement SystemK3.IAN.4469-09T2020-01-10
08800017261386EXULT Knee Replacement SystemK3.IAN.4469-10T2020-01-10
08800017261393EXULT Knee Replacement SystemK3.IAN.4469-11T2020-01-10
08800017261409EXULT Knee Replacement SystemK3.IAN.4469-12T2020-01-10
08800017261416EXULT Knee Replacement SystemK3.IAN.4469-13T2020-01-10
08800017261423EXULT Knee Replacement SystemK3.IAN.4469-14T2020-01-10
08800017261430EXULT Knee Replacement SystemK3.IAN.4469-16T2020-01-10
08800017261447EXULT Knee Replacement SystemK3.IAN.4469-18T2020-01-10
08800017261454EXULT Knee Replacement SystemK3.IAN.4572-09T2020-01-10
08800017261461EXULT Knee Replacement SystemK3.IAN.4572-10T2020-01-10
08800017261478EXULT Knee Replacement SystemK3.IAN.4572-11T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203692Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203708Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203715Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203722Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203739Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203746Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203753Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203760Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203777Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203784Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203791Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203807Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203814Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203821Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203838Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203845Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203852Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203869Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203876Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203883Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203890Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203906Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203913Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203920Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06