Vilex Fibula Tool ZF-TARG-T

GUDID 00841731123282

Targeting, Fibula Nail, Short Screw

VILEX IN TENNESSEE, INC.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

Primary Device ID	00841731123282
NIH Device Record Key	e1f14b8b-d0a4-4b92-a095-fa0ef0a7c147
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Fibula Tool
Version Model Number	ZF-TARG-T
Catalog Number	ZF-TARG-T
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	false
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	00841731123282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151456

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories