AccessGUDID - DEVICE: Canaveral® (B183115950800)

GUDID

Device Identifier (DI) Information

Brand Name: Canaveral®
Version or Model: Canaveral®
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-1595-80
Company Name: FLOSPINE LLC

Primary DI Number: B183115950800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042993143 *Terms of Use

Device Description: Reduction Monoaxial Screw, 9.5mm x 80mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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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 [?]
K141850	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4b0cf99e-b082-4ad3-8832-4a8d91431e94
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 30, 2016