DEVICE: Canaveral® (B183171000250)

Device Identifier (DI) Information

Canaveral®
Canaveral®
In Commercial Distribution
01-7000-025
FLOSPINE LLC
B183171000250
HIBCC

1
042993143 *Terms of Use
In-Situ Rod Bender, Right
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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
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
KWP Appliance, Fixation, Spinal Interlaminal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141850 000
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

2a47c164-699c-43aa-9e90-8eb8f5a22357
July 06, 2018
3
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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