DEVICE: EVEREST Spinal System (10888857410787)
Device Identifier (DI) Information
EVEREST Spinal System
2901-66030-G1
In Commercial Distribution
2901-66030-G1
K2M, INC.
2901-66030-G1
In Commercial Distribution
2901-66030-G1
K2M, INC.
Contoured Rod, Size Dia. 6.0x30 mm, Ti
Device Characteristics
MR Conditional | |
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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
MNH | Orthosis, spondylolisthesis spinal fixation |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNI | Orthosis, spinal pedicle fixation |
KWQ | Appliance, fixation, spinal intervertebral body |
NKB | Thoracolumbosacral pedicle screw system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30 Millimeter |
Outer Diameter: 6 Millimeter |
Device Record Status
40df74f9-bb82-4442-96b2-300d50bb6a8d
July 31, 2023
3
October 07, 2019
July 31, 2023
3
October 07, 2019
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(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com