DEVICE: CREO (00889095126075)
Device Identifier (DI) Information
CREO
5119.9670
In Commercial Distribution
GLOBUS MEDICAL, INC.
5119.9670
In Commercial Distribution
GLOBUS MEDICAL, INC.
CREO® Threaded 6.5 x 70mm Uniplanar Fracture Reduction Screw
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
MNH | Orthosis, spondylolisthesis spinal fixation |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K124058 | 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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Outer Diameter: 6.5 Millimeter |
Length: 70 Millimeter |
Device Record Status
df7f4cb4-a017-447a-8abb-f6ef49b60848
July 06, 2018
4
October 14, 2015
July 06, 2018
4
October 14, 2015
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 |
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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(610)930-1800
info@globusmedical.com
info@globusmedical.com