AccessGUDID - DEVICE: Fortex Pedicle Screw System (M697X07705151)

GUDID

Device Identifier (DI) Information

Brand Name: Fortex Pedicle Screw System
Version or Model: X077-0515
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697X07705151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: CoCr, Pre-Bent Rods, 5.5mm Dia Bar X 140mm

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?
65116	Bone-screw internal spinal fixation system rod	An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation
MNI	Orthosis, spinal pedicle fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090224	000
K120832	000
K152132	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
Length: 140 Millimeter
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: dfb919d2-81e7-45af-89f5-aa270b892572
Public Version Date: November 20, 2024
Public Version Number: 6
DI Record Publish Date: October 24, 2015