DEVICE: INnate Instrument Kit (B487EXINN9145000)
Device Identifier (DI) Information
INnate Instrument Kit
EXINN914500
Not in Commercial Distribution
EXINN914500
Exsomed Corporation
EXINN914500
Not in Commercial Distribution
EXINN914500
Exsomed Corporation
INnate Sterile Instrument Kit
The kit contains two guide wires, one cannulated drill, and one cannulated driver.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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32865 | Orthopaedic implant driver |
A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.
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Active | false |
62729 | Orthopaedic guidewire, single-use |
A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.
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Active | false |
61235 | Cannulated surgical drill bit, single-use |
A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
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Active | false |
58796 | Surgical depth gauge, single-use |
A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced; or 3) a cylindrical rod with markings. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HXI | Passer, Wire, Orthopedic |
LXH | Orthopedic Manual Surgical Instrument |
HTW | Bit, Drill |
HTJ | Gauge, Depth |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e1f8e24f-3d5d-4051-830c-8f9f12006519
September 11, 2024
11
April 09, 2018
September 11, 2024
11
April 09, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined