DEVICE: FacetFuse® (00190361018742)
Device Identifier (DI) Information
FacetFuse®
01-00018-ST5550
In Commercial Distribution
SPINEFRONTIER, INC.
01-00018-ST5550
In Commercial Distribution
SPINEFRONTIER, INC.
Facet Screw Assy SOTW, Fixed15MM, 5.5x50
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37272 | Trans-facet-screw internal spinal fixation system, sterile |
A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRW | SYSTEM, FACET SCREW SPINAL DEVICE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K071420 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 50 Millimeter |
Outer Diameter: 5.5 Millimeter |
Device Record Status
ea404ea1-ba6e-4699-bd57-289f887ebff8
July 06, 2018
4
April 15, 2016
July 06, 2018
4
April 15, 2016
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
[?]
+1(866)914-7717
customerservice@spinefrontier.com
customerservice@spinefrontier.com