FDA.reportPublic FDA data

MEDINAUT Plus Kyphoplasty System

Primary DI
08800038031999
Brand
MEDINAUT Plus Kyphoplasty System
Company
IMEDICOM CO., LTD.
Model
MCX-BI
Published
2019-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
HXGTamp
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HXGTampOrthopedic1
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182287000MEDINAUT PlusImedicom Co., Ltd.2019-04-06HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038031999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038031999088000380319998800038031999

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic cement mixer, single-useA sterile hand-operated device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically consists of a vessel with attached/attachable mixing blades where the cement is mixed. It may include a plunger unit used to transfer the mixed cement from the vessel into an applicator prior to the surgical procedure, and a suction tube to enable connection to a separate fume extraction device. It is typically operated outside of the sterile surgical field and is not intended to contact the patient. This is a single-use device.

Regulatory Flags#

DUNS number
690340653
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800038060807EZImpactorBMA-P20-IW12026-04-21
08800038060814EZImpactorBMA-P20-SW12026-04-21
08800038060784EZImpactorBMA-P10-IW12026-04-01
08800038060791EZImpactorBMA-P10-SW12026-04-01
08800038060319EZImpactorBMA-P10-I012026-01-22
08800038060326EZImpactorBMA-P10-S012026-01-22
08800038060333EZImpactorBMA-P20-I012026-01-22
08800038060340EZImpactorBMA-P20-S012026-01-22
08404535020120Brasseler EZXBRXTR2-0012025-10-10
08800038029323SteriSpine VA KITKYPHO102025-09-24
08800038029330SteriSpine VA KITKYPHO152025-09-24
08800038029347SteriSpine VA KITKYPHO202025-09-24
08800038029354SteriSpine VA KITKYPHO10B2025-09-24
08800038029361SteriSpine VA KITKYPHO15B2025-09-24
08800038029378SteriSpine VA KITKYPHO20B2025-09-24
08800038029415SteriSpine VA SPICD-CA2/ SPICD-NDB22025-09-24
08800038029422SteriSpine VA SPICD-CA2/ SPICD-NDT22025-09-24
08800038039407SteriSpine VA SPICD-CA1/ SPICD-NDB12025-09-24
08800038039414SteriSpine VA SPICD-CA1/ SPICD-NDD12025-09-24
08800038039421SteriSpine VA SPICD-CA1/ SPICD-NDT12025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
B8035506760ORTHOMEDORTHO-MED, INC.HXG2026-06-22
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08800322752098AnyPlus®GS Medical Co., Ltd.HXG2026-01-28
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
07613327638226OmnicurveSTRYKER CORPORATIONHRX2024-09-03