FDA.reportPublic FDA data

Vertebra Filler Device (Frontal Opening)

Primary DI
04250203940924
Brand
Vertebra Filler Device (Frontal Opening)
Company
Joline GmbH & Co. KG
Model
US9601
Published
2020-08-14
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192449000Joline Kyphoplasty System AllevoJoline GmbH & Co. KG2020-05-27NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250203940924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250203940924042502039409244250203940924

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342087108
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250203943482QuattroMixUS96202026-03-03
04250203940399Best Kit Stop'n GO 2 x 8 mmUS7OA22002020-08-14
04250203940405Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7ON12002020-08-14
04250203940436Best Kit SpeedTrack Stop'n GO 2 x 8 mmUS7OS22002020-08-14
04250203940443Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7OR22002020-08-14
04250203940450Best Kit Stop'n GO 2 x 8 mmUS7HA22002020-08-14
04250203940467Best Kit SpeedTrack Stop'n GO 2 x 8 mmUS7HS22002020-08-14
04250203940474Best Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7HR22002020-08-14
04250203940481Best Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7HN12002020-08-14
04250203940535Best Kit 16/16US7OA21102020-08-14
04250203940542Best Kit 22/16US7OA21202020-08-14
04250203940559Best Kit 16/16US7HA21102020-08-14
04250203940566Best Kit 22/16US7HA21202020-08-14
04250203940733Vertebra Access Device with Bevel Tip Needle & StyletUS91042020-08-14
04250203940771RapidIntro Trocar Tip Introducer Cannula & StyletUS92112020-08-14
04250203940498Smart Kit Stop'n GO 2 x 8 mmUS7NA22002020-08-14
04250203940504Smart Kit SpeedTrack Stop'n GO 2 x 8 mmUS7NS22002020-08-14
04250203940511Smart Kit RapidIntro Bevel Tip Stop'n GO 2 x 8 mmUS7NR22002020-08-14
04250203940528Smart Kit Mod. One Pedicle Stop'n GO 2 x 8 mmUS7NN12002020-08-14
04250203940573Smart Kit 16/16US7NA21102020-08-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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