3.5mm x 38mm Gridlock Ankle Screw

GUDID 00812926025735

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	00812926025735
NIH Device Record Key	b4dc0951-99be-4d25-8dab-34b53a78a1fc
Commercial Distribution Status	In Commercial Distribution
Brand Name	3.5mm x 38mm Gridlock Ankle Screw
Version Model Number	304-35-038
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

Outer Diameter	3.5 Millimeter
Outer Diameter	3.5 Millimeter
Outer Diameter	3.5 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter
Length	38 Millimeter
Outer Diameter	3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926025735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160177

FDA Product Code

HWC	Screw, Fixation, Bone