FDA.report

LOSPA IS Spinal System

Primary DI
08800017278049
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
20307701
Device description
DLIF extractor
Published
2022-10-21
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

Related Records

Contact Domains

Product Codes

CodeName
HWBExtractor

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800017278049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800017278049088000172780498800017278049

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82415857114sungwon.yang@corentec.com

Regulatory Flags

DUNS number
688739895
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
true
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 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 DIBrandCompanyProduct codePublished
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704039Fitmore Extraction Adapter - MZimmer, Inc.HWB2025-12-18
00889024704046Fitmore Extraction Adapter - FZimmer, Inc.HWB2025-12-18
03662663274128Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-18
03662663217415Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217439Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217446Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217453Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217460Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663279277Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-16
10603295505044ATTUNEDEPUY (IRELAND)HWB2025-12-11