DEVICE: FOCUS (00814008026135)
Device Identifier (DI) Information
FOCUS
PD-1000T-065
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-065
In Commercial Distribution
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Open Rod Pusher. 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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No | |
No | |
Yes | |
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No | |
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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? |
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44759 | General internal orthopaedic fixation system implantation kit |
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MDM | Instrument, Manual, Surgical, General Use |
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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Special Storage Condition, Specify: A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
49929fa3-727e-4e29-9e3c-4a304f37386d
January 20, 2020
2
December 15, 2018
January 20, 2020
2
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
[?]
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