STATIX

GUDID 00841731110114

Ring, Statix Full 180mm Black

VILEX IN TENNESSEE, INC.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

Primary Device ID	00841731110114
NIH Device Record Key	3001cbda-fab8-46c7-99d8-407a9ee925f5
Commercial Distribution Status	In Commercial Distribution
Brand Name	STATIX
Version Model Number	301-100-180
Company DUNS	152008371
Company Name	VILEX IN TENNESSEE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731110114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052196

FDA Product Code

KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component