FDA.reportPublic FDA data

Smart Kit SpeedTrack Stop'n GO 2 x 8 mm

Primary DI
04250203940504
Brand
Smart Kit SpeedTrack Stop'n GO 2 x 8 mm
Company
Joline GmbH & Co. KG
Model
US7NS2200
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
04250203940504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250203940504042502039405044250203940504

GMDN Terms#

Term, Definition table
TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342087108
Device count
1
Kit
true
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
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
04250203940580Smart Kit 22/16US7NA21202020-08-14

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