DEVICE: TiLock (M719GL304850)

Device Identifier (DI) Information

TiLock
1
In Commercial Distribution
GL304-85
Genesys Orthopedics Systems LLC
M719GL304850
HIBCC

1
017921066 *Terms of Use
Torque Limiter Handle - 85 in/lb
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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?
47858 Surgical instrument torque limiter
A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KWQ Appliance, Fixation, Spinal Intervertebral Body
KWP Appliance, Fixation, Spinal Interlaminal
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
NKB Thoracolumbosacral Pedicle Screw System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K172469 000
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

404a14c9-f5d4-4f3b-9ac0-2bc750281c7f
January 10, 2020
1
January 02, 2020
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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
5123817070
info@genesysspine.com
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