FDA.reportPublic FDA data

MEDINAUT Plus Kyphoplasty System

Primary DI
08809317171029
Brand
MEDINAUT Plus Kyphoplasty System
Company
IMEDICOM CO., LTD.
Model
MCX-00
Published
2019-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
08809317171029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317171029088093171710298809317171029

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive manual orthopaedic cement preparation kit, single-useA collection of multiple hand-operated, noninvasive devices (supplied together and labelled as a single product), designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer 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 does not include patient-contact devices. This is a single-use device.

Regulatory Flags#

DUNS number
690340653
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800038031999MEDINAUT Plus Kyphoplasty SystemMCX-BI2019-05-31
08809544171557MVX PlusMVX-P2017-04-10
08809544171564MVX USMVX-012017-04-10
08800038061286EZXEZX System 01S2026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337120308Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120605Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120643Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-23
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLNDN2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NDN2026-10-16
M9307631310010Life InstrumentsLife Instrument CorporationHXG2026-10-16
M9307631314010Life InstrumentsLife Instrument CorporationHXG2026-10-16
00884450843215StabiliT®Merit Medical Systems, Inc.NDN2026-04-15
00884450843222StabiliT®Merit Medical Systems, Inc.NDN2026-03-31
00810112598902TriLEAPSynthes GmbHHXG2026-02-10
03701505801204DynamoTEKNIMEDNDN2026-02-02
04260102139411OSTEOPAL®Heraeus Medical GmbHNDN2025-09-26
08033737113790HERNIATOMEADRIA SRLHRX2025-04-07
08033737119983HERNIATOMEADRIA SRLHRX2025-04-07
04048551411704NAKarl Storz GmbH & Co. KGHRX2025-03-27
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00846338002558EndiscopeELLIQUENCE, LLCHRX2025-01-09
00846338002589EndiscopeELLIQUENCE, LLCHRX2025-01-09
00846338002596EndiscopeELLIQUENCE, LLCHRX2025-01-09