DEVICE: ENDOSKELETON® TAS (00191375020950)
Device Identifier (DI) Information
ENDOSKELETON® TAS
2312-0112-S
In Commercial Distribution
2312-0112-S
TITAN SPINE, LLC
2312-0112-S
In Commercial Distribution
2312-0112-S
TITAN SPINE, LLC
Interbody Fusion Device 12 Degree Standard 12mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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 |
---|---|
Metallic spinal fusion cage, sterile | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVD | Intervertebral fusion device with integrated fixation, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K111626 | 000 |
K142589 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 12 Millimeter |
Device Size Text, specify: Lordotic Angle 12 Deg |
Device Size Text, specify: 32 x 21 (M/L x A/P) mm |
Device Record Status
53803340-448e-4547-ad3a-f7f227571def
July 06, 2018
3
December 15, 2016
July 06, 2018
3
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