DEVICE: 3DP Lumbar Interbody System (M719GLL103M08150)
Device Identifier (DI) Information
3DP Lumbar Interbody System
1
In Commercial Distribution
GLL103-M0815
Genesys Orthopedics Systems LLC
1
In Commercial Distribution
GLL103-M0815
Genesys Orthopedics Systems LLC
LLIF Ingot Rasp, 8mm x 15-Degree
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? |
---|---|---|---|---|
35559 | Bone file/rasp, manual, reusable |
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
MQP | Spinal Vertebral Body Replacement Device |
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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Length: 20 Millimeter |
Angle: 6 degree |
Device Record Status
989bce3a-48c8-4e9a-8b8d-f57f8a7ec926
April 22, 2024
1
April 12, 2024
April 22, 2024
1
April 12, 2024
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
[?]
512-381-7070
info@genesysspine.com
info@genesysspine.com