DEVICE: Excella II® (M711LS1750)

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Device Record History
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Device Identifier (DI) Information
Excella II®
LS-175
In Commercial Distribution

INNO Holdings, Inc.
M711LS1750
HIBCC

1
141620464 *Terms of Use
Radel, Silicone, SST
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32871 Surgical torque wrench, reusable
A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NKB Thoracolumbosacral Pedicle Screw System
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
KWP Appliance, Fixation, Spinal Interlaminal
KWQ Appliance, Fixation, Spinal Intervertebral Body
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
91c96a09-ed0f-4d62-aa15-2827899c33a9
January 08, 2026
3
March 31, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
801-261-2236
info@innovasis.com
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