AccessGUDID - DEVICE: Fortress Pedicale Screw (M7407405525)

GUDID

Device Identifier (DI) Information

Brand Name: Fortress Pedicale Screw
Version or Model: 10-10-57-7
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 740-5525
Company Name: SPINEOLOGY INC.

Primary DI Number: M7407405525
Issuing Agency: HIBCC
Commercial Distribution End Date: July 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Pedicle Screw

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Millimeter
Device Size Text, specify: 5.5x25

Device Record Status

Public Device Record Key: 72826949-017f-425b-9651-d1dff25d827f
Public Version Date: November 07, 2024
Public Version Number: 4
DI Record Publish Date: September 17, 2015