DEVICE: MESA® Spinal System (10888857263734)
Device Identifier (DI) Information
MESA® Spinal System
6201-07545-G1
In Commercial Distribution
6201-07545-G1
K2M, INC.
6201-07545-G1
In Commercial Distribution
6201-07545-G1
K2M, INC.
MESA 2 Deformity Polyaxial Screw Size Ø7.5x45 mm
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? |
---|---|---|---|---|
46651 | Spinal bone screw, non-bioabsorbable |
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
MNH | Orthosis, spondylolisthesis spinal fixation |
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: 45 Millimeter |
Outer Diameter: 7.5 Millimeter |
Device Record Status
f97a4855-9b36-455e-aa61-31fd1dc76952
October 04, 2024
7
June 14, 2016
October 04, 2024
7
June 14, 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(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com