DEVICE: ENDOSKELETON® TCS Sterile Barrier System (00191375025689)
Device Identifier (DI) Information
ENDOSKELETON® TCS Sterile Barrier System
5380-1611-S
Not in Commercial Distribution
5380-1611-S
TITAN SPINE, LLC
5380-1611-S
Not in Commercial Distribution
5380-1611-S
TITAN SPINE, LLC
Interbody Fusion Device Parallel Large 11mm
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? |
---|---|---|---|---|
38161 | Metallic spinal interbody fusion cage |
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral fusion device with bone graft, cervical |
OVE | Intervertebral fusion device with integrated fixation, cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142589 | 000 |
K142940 | 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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Depth: 16 Millimeter |
Device Size Text, specify: width(MLxAP), 18 x 16, mm |
Width: 18 Millimeter |
Height: 11 Millimeter |
Device Size Text, specify: Parallel |
Device Record Status
c017c7c1-d94b-4ee8-a5e8-e80f26bb286c
December 09, 2020
9
December 15, 2016
December 09, 2020
9
December 15, 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
[?]
+1(262)242-7801
productinfo@titanspine.com
productinfo@titanspine.com