DEVICE: VSP (10705034240848)

Device Identifier (DI) Information

VSP
222525A
Not in Commercial Distribution
222525A
DEPUY SPINE, LLC
10705034240848
GS1
July 31, 2018
1
107105876 *Terms of Use
VSP SPINE SYSTEM A-SLOT PLATE, TWO AND ONE HALF SLOT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Spinal fixation plate, non-bioabsorbable A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
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FDA Product Code

[?]
Product Code Product Code Name
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
MNH Orthosis, spondylolisthesis spinal fixation
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984350 000
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
No Device Sizes
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Device Record Status

0bd36055-60d3-4a22-b4cc-c0022056754f
July 31, 2018
5
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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