DEVICE: KangLi Pedicle Screw Spinal System (06937762164876)
Device Identifier (DI) Information
KangLi Pedicle Screw Spinal System
T6160200
Not in Commercial Distribution
T6160200
Suzhou Kangli Orthopaedics Instrument Co.,Ltd.
T6160200
Not in Commercial Distribution
T6160200
Suzhou Kangli Orthopaedics Instrument Co.,Ltd.
Rod (φ6.0)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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65116 | Bone-screw internal spinal fixation system rod |
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142290 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter: 6.0 mm |
Length: 200 Millimeter |
Device Record Status
b32a74af-a1a1-4063-aafb-04190d3184bf
June 12, 2024
5
September 03, 2016
June 12, 2024
5
September 03, 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 |
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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
[?]
No Customer Contact currently defined