DEVICE: 3DP Cervical Interbody System (M719GAC3D07LL0)
Device Identifier (DI) Information
3DP Cervical Interbody System
1
In Commercial Distribution
GAC3D-07LL
Genesys Orthopedics Systems LLC
1
In Commercial Distribution
GAC3D-07LL
Genesys Orthopedics Systems LLC
7mm 3DP Stand-Alone Cervical Interbody, Large Lordotic
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? |
---|---|---|---|---|
38161 | Metallic spinal interbody fusion cage |
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191489 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 7 Millimeter |
Device Record Status
125e6274-bfae-4771-ad26-e3d8d0485d43
July 03, 2020
1
June 25, 2020
July 03, 2020
1
June 25, 2020
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
[?]
5123817070
info@genesysspine.com
info@genesysspine.com