DEVICE: MESA® Small Stature Spinal System (10888857244399)
Device Identifier (DI) Information
MESA® Small Stature Spinal System
3001-B45300-G2
In Commercial Distribution
3001-B45300-G2
K2M, INC.
3001-B45300-G2
In Commercial Distribution
3001-B45300-G2
K2M, INC.
Straight Deformity Rod, Dual Hex Size Ø4.5x300 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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65116 | Bone-screw internal spinal fixation system rod |
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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KWQ | Appliance, fixation, spinal intervertebral body |
MNH | Orthosis, spondylolisthesis spinal fixation |
NKB | Thoracolumbosacral pedicle screw system |
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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: 300 Millimeter |
Outer Diameter: 4.5 Millimeter |
Device Record Status
d73bd252-84aa-4bdf-9c57-5a9c3ba12688
June 24, 2024
3
December 21, 2018
June 24, 2024
3
December 21, 2018
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
[?]
+1(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com