DEVICE: 15 (w) X 18 (d) Saber-C Cervical Plate (00810017912247)
Device Identifier (DI) Information
15 (w) X 18 (d) Saber-C Cervical Plate
CP-5897
In Commercial Distribution
CP-5897
ELEVATION SPINE, INC.
CP-5897
In Commercial Distribution
CP-5897
ELEVATION SPINE, INC.
Saber-C Plate, 15x18x7 9 deg.
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).
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Active | true |
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 |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K190885 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
9af87372-217e-48c0-82be-fb4b00fa2c21
July 16, 2024
2
December 30, 2019
July 16, 2024
2
December 30, 2019
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
844-415-0226
info@elevationspine.com
info@elevationspine.com