DEVICE: AVATAR Minimally Invasive Spinal System (00190837053208)

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Device Record History
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Device Identifier (DI) Information
AVATAR Minimally Invasive Spinal System
116-479
In Commercial Distribution
116-479
Life Spine, Inc.
00190837053208
GS1

1
183641617 *Terms of Use
Calipers
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
35788 Orthopaedic bone calliper
A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NKB Thoracolumbosacral pedicle screw system
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K111953 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
e0c6491a-88f4-4f2d-892e-a1dccf0488b5
December 04, 2024
2
November 07, 2019
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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

[?]
No Customer Contact currently defined
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