AccessGUDID - DEVICE: Superion™ (00884662000536)

GUDID

Device Identifier (DI) Information

Brand Name: Superion™
Version or Model: 101-9810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101-9810
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 00884662000536
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: Indirect Decompression System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61531	Lumbar decompression interspinous spacer	A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQO	Prosthesis, Spinous Process Spacer/Plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140004	000
P140004	004
P140004	015
P140004	016
P140004	017
P140004	024
P140004	025
P140004	027
P140004	030
P140004	032

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Millimeter

Device Record Status

Public Device Record Key: 7f1e4c1d-a8d8-43c3-81e1-310b653c67f2
Public Version Date: May 21, 2025
Public Version Number: 7
DI Record Publish Date: February 04, 2019