DEVICE: REVERE (00889095039979)
Device Identifier (DI) Information
REVERE
134.361
In Commercial Distribution
GLOBUS MEDICAL, INC.
134.361
In Commercial Distribution
GLOBUS MEDICAL, INC.
6.5mm REVERE 6.35 Cannulated Pedicle Screw 25mm
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 |
---|---|
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
MNH | Orthosis, spondylolisthesis spinal fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K091782 | 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: 25 Millimeter |
Device Record Status
ac33ecc9-dd43-4257-9a4e-83dfba6890b6
July 06, 2018
4
November 05, 2015
July 06, 2018
4
November 05, 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