DEVICE: Salvo® Spine System (10840642136029)

Device Identifier (DI) Information

Salvo® Spine System
11-6834
In Commercial Distribution
11-6834
Spine Wave, Inc.
10840642136029
GS1

1
067789763 *Terms of Use
8.5 x 35 mm Bone Screw, Cannulated, 3 mm Pitch
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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?
46651 Spinal bone screw, non-bioabsorbable
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
Active true
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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 [?]
K182954 000
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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
Outer Diameter: 8.5 Millimeter
Length: 35 Millimeter
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Device Record Status

cce8c580-7387-4769-9a52-fe12f0552ae5
September 11, 2024
3
October 26, 2021
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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

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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
No
No CLOSE

Customer Contact

[?]
203-944-9494
info@spinewave.com
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