DEVICE: Inion Hexalon instrument (M224INS920610)

Device Identifier (DI) Information

Inion Hexalon instrument
1
Not in Commercial Distribution
INS-9206
Inion Oy
M224INS920610
HIBCC
October 10, 2018
1
367994657 *Terms of Use
Starter, 8/9 mm
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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?
32859 Orthopaedic bone screw starter/notcher
A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JDR Staple, fixation, bone
HWC Screw, fixation, bone
MAI FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071464 000
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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

0b404234-2d59-4de8-a6a5-9afc64436cb0
October 11, 2018
5
August 31, 2016
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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

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Issuing Agency [?] Secondary DI Number
GS1 06438408002588
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Unit of Use DI

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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