FDA.reportPublic FDA data

HERNIATOME

Primary DI
08033737113844
Brand
HERNIATOME
Company
ADRIA SRL
Model
5091745
Device description
Percutaneous Discectomy Device
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141557000HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBARGallini Medical Devices, Srl2014-12-08HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033737113844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033737113844080337371138448033737113844

GMDN Terms#

Term, Definition table
TermDefinition
Diskectomy system, percutaneous, automaticAn automated system intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. This system is used to resect and aspirate the nucleus pulposus in one step, eliminating the need for repeated insertion of the nucleotome. It provides an alternative to surgical diskectomy and is typically carried out under local anaesthesia. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
437941789
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033737113790HERNIATOME50917152025-04-07
08033737119983HERNIATOME50917492025-04-07
08053175003439Vertebroplasty Injector Kit490000012025-04-07
08053175004238Hollow Drill4959308102025-04-07
08053175004382Cement Injection Cannula4950414202025-04-07
08053175016125Vertebroplasty Needle496322025-04-07
08033737117538Trocar T0604302024-08-13
08033737117545TrocarT0604312024-08-13
08033737117576Trocar T0604342024-08-13
08033737117583Trocar T0604352024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25
08800038058187SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038058200SYNTH™ PLUSIMEDICOM CO., LTD.HRX2024-03-22
08800038057906MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056336SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056343SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-31
08800038056145SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056176SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-19
08800038056183SYNTH™ CDSIMEDICOM CO., LTD.HRX2023-10-19
08800038055643SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2023-08-30