DEVICE: Valeo Spacer System (M555910093210)
Device Identifier (DI) Information
Valeo Spacer System
A
In Commercial Distribution
91.009.3210
AMEDICA CORPORATION
A
In Commercial Distribution
91.009.3210
AMEDICA CORPORATION
16x12mm, Valeo C Trial, 6° , 10mm, No Depth Stop
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61300 | Internal spinal fixation procedure kit, single-use |
A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
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: 10 Millimeter |
Width: 12 Millimeter |
Length: 16 Millimeter |
Device Record Status
56011d74-44e9-412f-9fee-b0623082b602
June 07, 2019
6
December 29, 2017
June 07, 2019
6
December 29, 2017
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
[?]
801-839-3500
customerservice@amedica.com
customerservice@amedica.com