DEVICE: SPINENET ACC ® (B047CTRC1400)

Device Identifier (DI) Information

SPINENET ACC ®
CTRC1400
In Commercial Distribution

SPINENET, LLC
B047CTRC1400
HIBCC

1
792052321 *Terms of Use
SPINENET ACC ® -Transportation Case
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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
Instrument tray A flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ODP Intervertebral Fusion Device With Bone Graft, Cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110733 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

000beec3-7d85-429a-a55b-f8f704e2e929
July 06, 2018
4
October 10, 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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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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