DEVICE: 14 (w) X 17 (d) Saber-C Cervical Plate (00810017911967)

Device Identifier (DI) Information

14 (w) X 17 (d) Saber-C Cervical Plate
CP-4709
In Commercial Distribution
CP-4709
ELEVATION SPINE, INC.
00810017911967
GS1

1
085718404 *Terms of Use
Saber-C Plate, 14x17x9 0 deg.
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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?
46653 Spinal fixation plate, non-bioabsorbable
A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it 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).
Active true
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral Fusion Device With Bone Graft, Cervical
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
KWQ Appliance, Fixation, Spinal Intervertebral Body
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K190885 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

1a0e13c1-615a-464a-bc92-6e0288dd2282
July 17, 2025
4
December 27, 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
Yes
Yes
No CLOSE

Customer Contact

[?]
844-415-0226
info@elevationspine.com
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