DEVICE: Canaveral® (B183115950800)
Device Identifier (DI) Information
Canaveral®
Canaveral®
In Commercial Distribution
01-1595-80
FLOSPINE LLC
Canaveral®
In Commercial Distribution
01-1595-80
FLOSPINE LLC
Reduction Monoaxial Screw, 9.5mm x 80mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthopaedic bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use. |
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 |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4b0cf99e-b082-4ad3-8832-4a8d91431e94
March 29, 2018
2
June 30, 2016
March 29, 2018
2
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 |
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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
[?]
(561) 705-3080
info@flospine.com
info@flospine.com