Excella III-D® E3U5535

GUDID M711E3U55350

Ti 6Al 4V (ELI)

Innovasis, Inc.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

Primary Device ID	M711E3U55350
NIH Device Record Key	e0ad10ee-fd9a-41cf-9828-17880339ec96
Commercial Distribution Status	In Commercial Distribution
Brand Name	Excella III-D®
Version Model Number	E3U5535
Catalog Number	E3U5535
Company DUNS	156567492
Company Name	Innovasis, Inc.
Device Count	1
DM Exempt	true
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 Dimensions

Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter
Outer Diameter	5.5 Millimeter
Length	35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711E3U55350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140238

FDA Product Code

NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease