DEVICE: XIA 3 (07613327002829)

Device Identifier (DI) Information

XIA 3
48233430
In Commercial Distribution
48233430
Stryker Corporation
07613327002829
GS1

1
149183167 *Terms of Use
UNIPLANAR SCREW
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61325 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNH Orthosis, spondylolisthesis spinal fixation
OSH Pedicle screw spinal system, adolescent idiopathic scoliosis
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
Length: 30.0 Millimeter
Device Size Text, specify: Diameter: 4.5 Millimeter
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Device Record Status

3ed5afc0-308b-4833-b775-9440e30b2932
June 21, 2023
6
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

[?]
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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