DEVICE: VERSANAIL®TIBIAL NAIL (00887868019005)
Device Identifier (DI) Information
VERSANAIL®TIBIAL NAIL
1812-12-345
In Commercial Distribution
181212345
Biomet Orthopedics, LLC
1812-12-345
In Commercial Distribution
181212345
Biomet Orthopedics, LLC
No description.
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
HTN | WASHER, BOLT NUT |
HTY | PIN, FIXATION, SMOOTH |
LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE |
JDW | PIN, FIXATION, THREADED |
HRS | PLATE, FIXATION, BONE |
HWC | Screw, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K032097 | 000 |
K111663 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 12MM X 34.5CM |
Device Record Status
d57a6b48-193a-47fd-bc63-feb629193772
July 06, 2018
3
October 24, 2015
July 06, 2018
3
October 24, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com