DEVICE: Impulse Interbody Spacer System (00842048136880)
Device Identifier (DI) Information
Impulse Interbody Spacer System
07-04T1322L12
In Commercial Distribution
07-04T1322L12
DEGEN MEDICAL, INC.
07-04T1322L12
In Commercial Distribution
07-04T1322L12
DEGEN MEDICAL, INC.
13H X 22L X 10W X 12DEG Impulse Lordotic Trial
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral fusion device with bone graft, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K201287 | 000 |
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: 13 Millimeter |
Width: 10 Millimeter |
Length: 22 Millimeter |
Angle: 12 degree |
Device Record Status
06094c59-dfd1-489a-9b43-9707dc42241d
December 28, 2021
1
December 20, 2021
December 28, 2021
1
December 20, 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 |
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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
[?]
+1(877)240-7838
customerservice@degenmedical.com
customerservice@degenmedical.com