DEVICE: Valeo Spacer System (M555110131611)
Device Identifier (DI) Information
Valeo Spacer System
B
In Commercial Distribution
11.013.1611
AMEDICA CORPORATION
B
In Commercial Distribution
11.013.1611
AMEDICA CORPORATION
Valeo PL, 9x21 , 6°, 11mm with Alternative Texture
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? |
---|---|---|---|---|
34170 | Vertebral body prosthesis |
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Height: 11 Millimeter |
Width: 21 Millimeter |
Length: 9 Millimeter |
Device Record Status
c7104362-11ac-4668-b896-5855f12eb595
February 24, 2020
5
January 01, 2018
February 24, 2020
5
January 01, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
801-839-3500
customerservice@amedica.com
customerservice@amedica.com