2.4 mm Cortical Screw, Self-tapping, Star Head, 26mm length

GUDID 08903993318034

2.4 mm Cortical Screw, Self-tapping, Star Head, 26mm length

Auxein Medical Private Limited

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 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	08903993318034
NIH Device Record Key	b1b6c9fd-bab7-42c6-a360-096b50ad2ccc
Commercial Distribution Status	In Commercial Distribution
Brand Name	2.4 mm Cortical Screw, Self-tapping, Star Head, 26mm length
Version Model Number	Ti-1144.26
Company DUNS	872194615
Company Name	Auxein Medical Private Limited
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	true
Expiration Date	false
Donation Id Number	true
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	08903993318034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211324

FDA Product Code

HWC	Screw, Fixation, Bone