DEVICE: ENDOSKELETON® TAS (00191375025733)

Device Identifier (DI) Information

ENDOSKELETON® TAS
2300-1314
In Commercial Distribution
2300-1314
TITAN SPINE, LLC
00191375025733
GS1

1
623316978 *Terms of Use
Fixed Angle Driver Ancillary Handle
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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
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) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LXH Orthopedic Manual Surgical Instrument
OVD Intervertebral fusion device with integrated fixation, lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111626 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

012503d8-d5dd-4d45-9821-d5d8e2b3b010
July 06, 2018
3
December 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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