DEVICE: KangLi Pedicle Screw Spinal System (06937762181972)

Device Identifier (DI) Information

KangLi Pedicle Screw Spinal System
T6290060
In Commercial Distribution
T6290060
Suzhou Kangli Orthopaedics Instrument Co.,Ltd.
06937762181972
GS1

1
527054774 *Terms of Use
EF 5.5 Crosslinks 60mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
65114 Bone-screw internal spinal fixation system connector
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140053 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter: 5.5 mm
Length: 60 Millimeter
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Device Record Status

94d7b077-bc9f-48c9-b55d-0aefa02b0377
September 11, 2024
6
September 03, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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