DEVICE: ENDOSKELETON® TCS (00191375010920)

Device Identifier (DI) Information

ENDOSKELETON® TCS
5346-1212
In Commercial Distribution
5346-1212
TITAN SPINE, LLC
00191375010920
GS1

1
623316978 *Terms of Use
Interbody Fusion Device 6 Degree Small 12mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Metallic spinal fusion cage, non-sterile A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
OVE Intervertebral fusion device with integrated fixation, cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142940 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Height: 12 Millimeter
Device Size Text, specify: Lordotic Angle 6 Deg
Device Size Text, specify: 14 x 12 (M/L x A/P) mm
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Device Record Status

d31d63fb-91c3-4c9d-b396-e9bf7d6f5964
July 06, 2018
3
December 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(262)242-7801
productinfo@titanspine.com
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