AccessGUDID - DEVICE: Rampart One Lumbar Interbody Fusion Device (M7404904515)

GUDID

Device Identifier (DI) Information

Brand Name: Rampart One Lumbar Interbody Fusion Device
Version or Model: 10-10-75-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 490-4515
Company Name: SPINEOLOGY INC.

Primary DI Number: M7404904515
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Rampart One 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?
60847	Polymeric spinal fusion cage, sterile	A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.	Obsolete	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 [?]
K163670	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Millimeter

Device Record Status

Public Device Record Key: ffbfc926-2106-44b9-9a89-8e1306c3226b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2017