DEVICE: Canaveral® (B183171000130)

Device Identifier (DI) Information

Canaveral®
Canaveral®
In Commercial Distribution
01-7000-013
FLOSPINE LLC
B183171000130
HIBCC

1
042993143 *Terms of Use
T-Handle Torque Wrench - 90inlb
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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.
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

31064094-0002-41bd-ae7b-e409b6f02d51
March 29, 2018
2
June 30, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
(561) 705-3080
info@flospine.com
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