Vilex Lag Screw, FT

GUDID 00841731106933

Screw, Fully Thrd. 2.5x16mm SS

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00841731106933
NIH Device Record Key	2311000c-5a0e-4af9-b1a8-483560d6415d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Lag Screw, FT
Version Model Number	FT25-16S-11
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	00841731106933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K973309

FDA Product Code

HWC	Screw, Fixation, Bone