AccessGUDID - DEVICE: Rampart One Lumbar Interbody Fusion System (M7401001316)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart One Lumbar Interbody Fusion System
Version or Model: 102-63-06-9
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100-1316
Company Name: SPINEOLOGY INC.

Primary DI Number: M7401001316
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Trial 16mm M 8°

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:	No
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?
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192047	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
Height: 16 Millimeter
Angle: 8 degree

Device Record Status

Public Device Record Key: 8ed52f04-a786-4364-8453-e26ff69e3678
Public Version Date: April 29, 2025
Public Version Number: 1
DI Record Publish Date: April 21, 2025