DEVICE: Arsenal Deformity Spinal Fixation System (00840967196848)

Device Identifier (DI) Information

Arsenal Deformity Spinal Fixation System
48001-045-24
In Commercial Distribution

ALPHATEC SPINE, INC.
00840967196848
GS1

1
602465783 *Terms of Use
Fixed Bridge, 4.5mm, 24mm
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
65114 Bone-screw internal spinal fixation system connector
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
Active true
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K152968 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

[?]
Size Type Text
Length: 24 Millimeter
Outer Diameter: 4.5 Millimeter
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Device Record Status

760ad8b8-b2ef-4d3d-9d61-3e6fb039af31
September 11, 2024
5
April 27, 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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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