AccessGUDID - DEVICE: Fortex Pedicle Screw System (M697X0227555SDDL1)

GUDID

Device Identifier (DI) Information

Brand Name: Fortex Pedicle Screw System
Version or Model: X022-7555SD-DL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697X0227555SDDL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: Assembly, Fortex, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 55

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?
61325	Bone-screw internal spinal fixation system, non-sterile	An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090224	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
Outer Diameter: 7.5 Millimeter
Length: 55 Millimeter

Device Record Status

Public Device Record Key: d5671d61-bfda-4af6-b7c0-b8296ced58f7
Public Version Date: June 03, 2021
Public Version Number: 5
DI Record Publish Date: October 19, 2015