DEVICE: Polyaxial Pedicle Screw (07290014064942)
Device Identifier (DI) Information
Polyaxial Pedicle Screw
86140
In Commercial Distribution
PREMIA SPINE LTD
86140
In Commercial Distribution
PREMIA SPINE LTD
Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x55 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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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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K150380 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 22 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 55 Millimeter |
Outer Diameter: 7.5 Millimeter |
Device Record Status
d12d306b-0b27-4ae0-9404-b8e9e1ae51b9
January 19, 2024
4
December 04, 2015
January 19, 2024
4
December 04, 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 |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined