DEVICE: ENDOSKELETON® TL (00191375023142)

Device Identifier (DI) Information

ENDOSKELETON® TL
7107-1311-S
In Commercial Distribution
7107-1311-S
TITAN SPINE, LLC
00191375023142
GS1

1
623316978 *Terms of Use
Interbody Fusion Device 7 Degree 50 (M/L) 22 (A/P) 11 mm
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MAX Intervertebral fusion device with bone graft, lumbar
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140055 000
K142589 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 50 Millimeter
Height: 11 Millimeter
Device Size Text, specify: Lordotic Angle 7 Deg
Width: 22 Millimeter
CLOSE

Device Record Status

75798f15-b34f-411d-b2c9-bbe1fa85be28
July 06, 2018
3
December 15, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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