FDA.reportPublic FDA data

Filler Kit

Primary DI
04250203940702
Brand
Filler Kit
Company
Joline GmbH & Co. KG
Model
US7ZN0000
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
04250203940702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250203940702042502039407024250203940702

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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