DEVICE: VERSANAIL®TIBIAL NAIL (00887868018596)

Device Identifier (DI) Information

VERSANAIL®TIBIAL NAIL
1812-09-345
In Commercial Distribution
181209345
Biomet Orthopedics, LLC
00887868018596
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Tibia nail, sterile A sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding 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.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K032097 000
K111663 000
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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: 9MM X 34.5CM
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Device Record Status

4a7b0f4f-5c97-446b-b7ee-a7ffdbb21c2e
July 06, 2018
3
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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