DEVICE: Canaveral® (B183173000070)
Device Identifier (DI) Information
Canaveral®
Canaveral®
In Commercial Distribution
01-7000-007
FLOSPINE LLC
Canaveral®
In Commercial Distribution
01-7000-007
FLOSPINE LLC
Nav Screw Tap, 10.5mm
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 feeler | A hand-held manual surgical instrument designed to identify the position and/or shape of bone structures and/or cavities created within these structures, e.g., the angle of a drilled hole, during surgery. It is typically designed as a long, thin, shaft with a handle or handle connector at the proximal end and typically a round ball-tip at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to recognize structures and cavities through a tactile feedback. This is a reusable device. |
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fc3558e4-018d-4b6a-9a59-464203252e56
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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