DEVICE: Bendini (00887517094698)

Device Identifier (DI) Information

Bendini
8210010
In Commercial Distribution

Nuvasive, Inc.
00887517094698
GS1

1
053950783 *Terms of Use
Bendini Cable Box
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Spinal rod bending system An assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
OLO Orthopedic stereotaxic instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K122742 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

55af2d1b-d172-4eb5-8f2d-c3ec9378310d
July 06, 2018
3
October 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
No Secondary DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
No CLOSE

Customer Contact

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+1(858)909-1800
RA_UDI@nuvasive.com
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