DEVICE: CROSS-FUSE™* II PEEK VBR/IBF SYSTEM (00846468008147)

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Device Identifier (DI) Information

CROSS-FUSE™* II PEEK VBR/IBF SYSTEM
38-1855-11-6L

Pioneer Surgical Technology, Inc.
00846468008147
GS1
1
Crossfuse II Imp, 18x55x11, 6º lordosis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Vertebral body prosthesis, sterile A sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials.
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FDA Product Code

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Product Code Product Code Name
MAX Intervertebral fusion device with bone graft, lumbar
MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODP Intervertebral fusion device with bone graft, cervical
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Sterilization

Yes
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 Status

In Commercial Distribution
December 21, 2015

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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
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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