DEVICE: ENDOSKELETON® TCS (00191375011842)
Device Identifier (DI) Information
ENDOSKELETON® TCS
5210-1004
In Commercial Distribution
5210-1004
TITAN SPINE, LLC
5210-1004
In Commercial Distribution
5210-1004
TITAN SPINE, LLC
NO 8 HEXALOBE, STRAIGHT DRIVER
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 |
---|---|
Orthopaedic implant inserter/extractor | A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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 |
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No Device Sizes |
Device Record Status
ccbfb2e6-d1c0-4283-9c64-f2c0c5f922d4
December 07, 2018
5
December 15, 2016
December 07, 2018
5
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