DEVICE: ENDOSKELETON® TCS (00191375011736)
Device Identifier (DI) Information
ENDOSKELETON® TCS
5086-1605
In Commercial Distribution
5086-1605
TITAN SPINE, LLC
5086-1605
In Commercial Distribution
5086-1605
TITAN SPINE, LLC
6 DEG LORDOTIC, TRIAL, LARGE, 5MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Spinal implant trial | A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVE | Intervertebral fusion device with integrated fixation, cervical |
ODP | Intervertebral fusion device with bone graft, cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142940 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 18 x 16 (M/L x A/P) mm |
Device Size Text, specify: Lordotic Angle 6 Deg |
Height: 5 Millimeter |
Device Record Status
7883e530-a3df-4aa2-a8b4-64bb27ad755f
February 07, 2019
4
December 15, 2016
February 07, 2019
4
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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