FDA.reportPublic FDA data

LOSPA IS Spinal Fixation System

Primary DI
08806373893728
Brand
LOSPA IS Spinal Fixation System
Company
Corentec Co., Ltd
Model
SI.0P0.0002
Device description
Spinal Instrument - Probe Curved
Published
2020-03-27
Public version status
New
Distribution status
Not 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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373893728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373893728088063738937288806373893728

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
DM exempt
false
Premarket exempt
false
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
08809945895076EXULT Surgical InstrumentKZ.024.Z0232026-03-23
08806373887703BENCOX Surgical Instruments01.51.7532026-02-23
08809945895021EXULT Surgical InstrumentKZ.024.Z0182026-02-20
08809945895038EXULT Surgical InstrumentKZ.024.Z0192026-02-20
08809945895045EXULT Surgical InstrumentKZ.024.Z0202026-02-20
08809945895052EXULT Surgical InstrumentKZ.024.Z0212026-02-20
08809945895069EXULT Surgical InstrumentKZ.024.Z0222026-02-20
08809945895083EXULT Surgical InstrumentKZ.024.Z0242026-02-20
08809945895090EXULT Surgical InstrumentKZ.024.Z0252026-02-20
08809945895106EXULT Surgical InstrumentKZ.024.Z0262026-02-20
08809945895113EXULT Surgical InstrumentKZ.024.Z0272026-02-20
08809945895120EXULT Surgical InstrumentKZ.024.Z0282026-02-20
08800017271101Bencox Hip SystemHA.02J.00012018-11-21
08800017278230Bencox Hip SystemHZ.012.00012018-11-22
08800017285405Bencox Hip SystemHA.0B2.00012018-11-22
08800017299358BENCOX Surgical Instruments01.51.771.062026-01-12
08806373874215Bencox Hip SystemHA.013.00042018-11-21
08806373887734BENCOX Surgical Instruments01.51.7712026-01-12
08806373887826BENCOX Surgical Instruments01.51.8882026-01-12
08806373887833BENCOX Surgical Instruments01.51.888.012026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-19
00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
00840283402203VyPlate™VY SPINE LLCKWQ2026-03-19
08800071055440ASTEROSTEONIC CO.,Ltd.KWQ2026-03-19
00763000889982VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000889999VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890001VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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00763000890094VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890100VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890117VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890124VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890131VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890148VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890155VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890162VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890179VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890186VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
00763000890193VENTURE™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-03-16
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