1st MPJ Met Head Implant

GUDID 00841731106322

Cannulated Metatarsal Hemi Implant 14mm HA Coated

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	00841731106322
NIH Device Record Key	0b31a3a9-d794-4641-bc69-aca2147daa8b
Commercial Distribution Status	In Commercial Distribution
Brand Name	1st MPJ Met Head Implant
Version Model Number	CMHI-14
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	00841731106322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070052

FDA Product Code

KWD	Prosthesis, Toe, Hemi-, Phalangeal