DEVICE: ENDOSKELETON® TCS (00191375011514)

Device Identifier (DI) Information

ENDOSKELETON® TCS
5302-3515
Not in Commercial Distribution
5302-3515
TITAN SPINE, LLC
00191375011514
GS1
September 18, 2020
1
623316978 *Terms of Use
Bone Screw, Locking, 3.5mm x 15mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46651 Spinal bone screw, non-bioabsorbable
A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
OVE Intervertebral fusion device with integrated fixation, cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151596 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 3.8 Millimeter
Device Size Text, specify: Locking Bone Screw
Device Size Text, specify: 3.5mm Diameter, 15mm Length, No. 8 Hexalobe
Length: 15 Millimeter
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Device Record Status

f1f1290f-2b1f-4b8a-8154-215e775dec6d
January 03, 2024
11
December 15, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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