FDA.reportPublic FDA data

EZX

Primary DI
08800038060296
Brand
EZX
Company
IMEDICOM CO., LTD.
Model
XTR2-003
Device description
EZX (Upper Tray)
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038060296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038060296088000380602968800038060296

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690340653
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800038031999MEDINAUT Plus Kyphoplasty SystemMCX-BI2019-05-31
08809317171029MEDINAUT Plus Kyphoplasty SystemMCX-002019-05-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810240701137G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701144G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701151G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
07630055307743ROSA® Hip CT Instrument Tray - ShortIncipio Devices SAFSM2026-11-05
07630055307750ROSA® Hip CT Instrument Tray - TallIncipio Devices SAFSM2026-11-05
10889950159429Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-11-05
00889024713505G7® TM Acetabular SystemZimmer, Inc.FSM2026-11-03
05055662976694Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
05055662976717Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
08800322759509GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704070GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704087Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
08800424704094Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
B382SD9233161140Surgical DirectSurgical Direct, Inc.FSM2026-11-03
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02