FDA.reportPublic FDA data

LOSPA IS Spinal System

Primary DI
08800068943521
Brand
LOSPA IS Spinal System
Company
Corentec Co., Ltd
Model
217100068
Device description
Bone Traction Needle,110mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800068943521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800068943521088000689435218800068943521

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 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
00810158219335PRINCETONPrinceton Medical Group, Inc.HXK2026-03-12
00810158219113PRINCETONPrinceton Medical Group, Inc.HXK2026-03-11
04058749027327NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749027457NAFehling Instruments GmbH & Co. KGHXK2026-03-05
04058749028102NAFehling Instruments GmbH & Co. KGHXK2026-03-05
00810158218772PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
00810158218819PRINCETONPrinceton Medical Group, Inc.HXK2026-02-05
B356DF370170American MedicalsAmerican MedicalsHXK2026-01-30
04058749027990NAFehling Instruments GmbH & Co. KGHXK2026-01-28
04058749028003NAFehling Instruments GmbH & Co. KGHXK2026-01-28
00840217910125Wiggins medicalEbner Medical, LLCHXK2025-12-10
00840217910163Wiggins medicalEbner Medical, LLCHXK2025-12-10
04058749026764NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027471NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749027495NAFehling Instruments GmbH & Co. KGHXK2025-12-08
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016287INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-12-02
00757770676446Bausch + LombBausch & Lomb IncorporatedHXK2025-11-14
00841336107632Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCHXK2025-09-28
00840314270078gSourceGSOURCE LLCHXK2025-09-21
00810158217065PRINCETONPrinceton Medical Group, Inc.HXK2025-09-18
00810158216792PRINCETONPrinceton Medical Group, Inc.HXK2025-09-02
04058749028232NAFehling Instruments GmbH & Co. KGHXK2025-09-01
04058749026771NAFehling Instruments GmbH & Co. KGHXK2025-08-29
00840217909822Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909839Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909853Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909860Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909884Wiggins medicalEbner Medical, LLCHXK2025-08-20
00840217909907Wiggins medicalEbner Medical, LLCHXK2025-08-20