AccessGUDID - DEVICE: AUDERE POSTERIOR LUMBAR SPACER SYSTEM (00857215007054)

GUDID

Device Identifier (DI) Information

Brand Name: AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Version or Model: 10251400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10251400
Company Name: MET 1 TECHNOLOGIES, LLC

Primary DI Number: 00857215007054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080474650 *Terms of Use

Device Description: THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR AS A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH.

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:	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?
61958	Ceramic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a ceramic material [e.g., silicon nitride] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160699	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
Length: 25 Millimeter
Height: 14 Millimeter

Device Record Status

Public Device Record Key: 7fa932f6-f8c2-4ad0-8e9b-4d62d257b6ab
Public Version Date: February 24, 2020
Public Version Number: 4
DI Record Publish Date: May 29, 2017