FDA.reportPublic FDA data

INNOVERSE Spinal System

Primary DI
08800247363317
Brand
INNOVERSE Spinal System
Company
CG MedTech Co.,Ltd.
Model
NP0200
Published
2024-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800247363317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800247363317088002473633178800247363317

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688811082
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800247359822UniSpace® TPLIF CageTU02902026-06-27
08800247359839UniSpace® TPLIF CageTU03002026-06-27
08800247359846UniSpace® TPLIF CageTU03102026-06-27
08800247359853UniSpace® TPLIF CageTU03202026-06-27
08800247359860UniSpace® TPLIF CageTU03302026-06-27
08800247359877UniSpace® TPLIF CageTU03402026-06-27
08800247359884UniSpace® TPLIF CageTU03502026-06-27
08800247359891UniSpace® TPLIF CageTU01702026-06-27
08800247359907UniSpace® TPLIF CageTU01802026-06-27
08800247359914UniSpace® TPLIF CageTU01902026-06-27
08800247359921UniSpace® TPLIF CageTU02002026-06-27
08800247359938UniSpace® TPLIF CageTU02102026-06-27
08800247359945UniSpace® TPLIF CageTU02202026-06-27
08800247359952UniSpace® TPLIF CageTU02302026-06-27
08800247359969UniSpace® TPLIF CageTU02402026-06-27
08800247359976UniSpace® TPLIF CageTU02502026-06-27
08800247359983UniSpace® TPLIF CageTU02602026-06-27
08800247359990UniSpace® TPLIF CageTU02702026-06-27
08800308485811ANAX™ OCT SPINAL SYSTEMOSS07502026-05-13
08800037574725Velofix™ SA Cervical CageTS09122026-05-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17