DEVICE: PressON™ (B6785208800)
Device Identifier (DI) Information
PressON™
520880
In Commercial Distribution
NEXUS SPINE, L.L.C.
520880
In Commercial Distribution
NEXUS SPINE, L.L.C.
Max Telescoping Hybrid Coupler 28mm
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? |
---|---|---|---|---|
61324 | Bone-screw internal spinal fixation system, sterile |
An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNI | Orthosis, Spinal Pedicle Fixation |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133287 | 000 |
K160820 | 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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Length: 28 Millimeter |
Device Record Status
6aa1fbe0-ffd4-45c9-84ca-322e5d7549d6
June 09, 2023
2
April 30, 2022
June 09, 2023
2
April 30, 2022
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
[?]
No Customer Contact currently defined