AccessGUDID - DEVICE: PivoRod MIS Curved Rod 5.5 x 180 (M739245531800)

GUDID

Device Identifier (DI) Information

Brand Name: PivoRod MIS Curved Rod 5.5 x 180
Version or Model: 2455-3180
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CAPTIVA SPINE, INC.

Primary DI Number: M739245531800
Issuing Agency: HIBCC
Commercial Distribution End Date: October 21, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 836975784 *Terms of Use

Device Description: PivoRod MIS Curved Rod 5.5 x 180

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47779	Orthopaedic instrument surgical connector	A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNI	Orthosis, Spinal Pedicle Fixation
MNH	Orthosis, Spondylolisthesis Spinal Fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122332	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 979eefd6-83b5-4a7f-b6e1-c8ab8b159890
Public Version Date: December 07, 2018
Public Version Number: 4
DI Record Publish Date: August 28, 2015