DEVICE: Bone Filler Device (06938695525000)
Device Identifier (DI) Information
Bone Filler Device
FG2500
In Commercial Distribution
FG2500
Shanghai Kinetic Medical Co., Ltd.
FG2500
In Commercial Distribution
FG2500
Shanghai Kinetic Medical Co., Ltd.
KMC Kyphoplasty System consists of four components:
Balloon Catheter
Tool Kit (including Bone Filler Device, Dilator, Cannula, Drill and Guide Wire)
Puncture Needle
KMC Medical Balloon Catheter Syringe Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47997 | Bone grafting cannula |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRX | Arthroscope |
NDN | Cement, Bone, Vertebroplasty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K113742 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: less than 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fd070d79-4f5f-41f4-8d50-9bfe69eb012c
February 07, 2019
4
December 05, 2016
February 07, 2019
4
December 05, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+862150720558
qingmeiwei@kineticmedinc.com
qingmeiwei@kineticmedinc.com