3.5mm x 48mm Gridlock Ankle Screw

GUDID 00812926025780

TRILLIANT SURGICAL, LTD.

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 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	00812926025780
NIH Device Record Key	9f8bbe03-4904-434f-8056-f4e6d63ed2ef
Commercial Distribution Status	In Commercial Distribution
Brand Name	3.5mm x 48mm Gridlock Ankle Screw
Version Model Number	304-35-048
Company DUNS	828829072
Company Name	TRILLIANT SURGICAL, LTD.
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	48 Millimeter
Length	48 Millimeter
Length	48 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter
Outer Diameter	3.5 Millimeter
Length	48 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926025780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160177

FDA Product Code

HWC	Screw, Fixation, Bone