DEVICE: VERSANAIL®TIBIAL NAIL (00887868018893)

Device Identifier (DI) Information

VERSANAIL®TIBIAL NAIL
1812-11-375
In Commercial Distribution
181211375
Biomet Orthopedics, LLC
00887868018893
GS1

1
129278169 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
38152 Tibia nail
A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HSB ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTN WASHER, BOLT NUT
KTT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
HTY PIN, FIXATION, SMOOTH
HRS PLATE, FIXATION, BONE
JDW PIN, FIXATION, THREADED
HWC Screw, fixation, bone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Device Size Text, specify: 11MM X 37.5CM
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Device Record Status

6edf2c56-c3ac-4120-91c4-b19fb412f818
December 08, 2022
5
October 24, 2015
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
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