DEVICE: FOCUS (00814008027460)
Device Identifier (DI) Information
FOCUS
S-01-055
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
S-01-055
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Rod, Straight 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
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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NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K180458 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 55 Millimeter |
Outer Diameter: 5.5 Millimeter |
Device Record Status
550f9e57-ccfe-49d3-aa6b-ed5d7b27ff12
November 15, 2024
3
December 15, 2018
November 15, 2024
3
December 15, 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
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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
[?]
210-545-3713
Diana@nvisionbiomed.com
Diana@nvisionbiomed.com