DEVICE: Canaveral® (B183173000050)
Device Identifier (DI) Information
Canaveral®
Canaveral®
In Commercial Distribution
01-7000-005
FLOSPINE LLC
Canaveral®
In Commercial Distribution
01-7000-005
FLOSPINE LLC
Nav Screw Tap, 8.5mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
47862 | Abdominal/ENT/orthopaedic surgical probe, reusable |
A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWP | Appliance, Fixation, Spinal Interlaminal |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
MNI | Orthosis, Spinal Pedicle Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141850 | 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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No Device Sizes |
Device Record Status
f79b0663-fd50-470f-b333-a41b1407da5e
January 20, 2023
4
June 30, 2016
January 20, 2023
4
June 30, 2016
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
[?]
(561) 705-3080
info@flospine.com
info@flospine.com