DEVICE: NA (00840085209932)
Device Identifier (DI) Information
NA
GZC10A08A
In Commercial Distribution
GZC10A08A
HYHTE HOLDINGS, INC.
GZC10A08A
In Commercial Distribution
GZC10A08A
HYHTE HOLDINGS, INC.
LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT
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? |
---|---|---|---|---|
44788 | Spinal implant trial |
A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 18 Millimeter |
Height: 8 Millimeter |
Angle: 0 degree |
Device Record Status
d6ff7717-54f4-419c-9288-3ea5f3405461
July 22, 2021
1
July 14, 2021
July 22, 2021
1
July 14, 2021
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
[?]
7608148047
PARKER@ASTURAMEDICAL.COM
PARKER@ASTURAMEDICAL.COM