DEVICE: ENDOSKELETON® TCS (00191375028345)

Device Identifier (DI) Information

ENDOSKELETON® TCS
5210-1017
Not in Commercial Distribution
5210-1017
TITAN SPINE, LLC
00191375028345
GS1
September 18, 2020
1
623316978 *Terms of Use
Graft Packing & Screw Reference Block
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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
Bone graft packing block A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K142940 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
Height: 1 Inch
Width: 2 Inch
Length: 1.5 Inch
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Device Record Status

3a044999-4442-4669-a003-f98a98944092
December 09, 2020
4
September 30, 2019
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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

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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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