DEVICE: XIA 3 (07613327002713)

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Device Identifier (DI) Information

XIA 3
482376550
482376550
Stryker Corporation
07613327002713
GS1
1
CLOSED HEAD POLYAXIAL SCREW
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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
Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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FDA Product Code

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Product Code Product Code Name
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
MNH Orthosis, spondylolisthesis spinal fixation
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
OSH Pedicle screw spinal system, adolescent idiopathic scoliosis
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
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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
Length: 50.0 Millimeter
Device Size Text, specify: Diameter: 6.5 Millimeter
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Device Status

In Commercial Distribution
December 08, 2014

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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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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