AccessGUDID - DEVICE: Aries-L Lateral Lumbar Interbody System (B06214508405)

GUDID

Device Identifier (DI) Information

Brand Name: Aries-L Lateral Lumbar Interbody System
Version or Model: 1450-8405
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1450-8405
Company Name: Osseus Fusion Systems, LLC

Primary DI Number: B06214508405
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933442068 *Terms of Use

Device Description: 10mm Disc Evacuator, Lateral

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:	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?
37837	Orthopaedic osteotome blade, reusable	A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181347	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
No Device Sizes

Device Record Status

Public Device Record Key: de96bdfe-53af-431d-b5b9-22a9bae6f830
Public Version Date: August 20, 2020
Public Version Number: 2
DI Record Publish Date: May 12, 2020