AccessGUDID - DEVICE: AVS Anchor-L (07613252602101)

GUDID

Device Identifier (DI) Information

Brand Name: AVS Anchor-L
Version or Model: 48662204
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 48662204
Company Name: Stryker Corporation

Primary DI Number: 07613252602101
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 149183167 *Terms of Use

Device Description: VERTEBRAL SPACER

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?
60762	Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
OVD	Intervertebral fusion device with integrated fixation, lumbar
MAX	Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Angle: 4.0 degree
Length: 22.0 Millimeter
Width: 30.0 Millimeter
Height: 20.0 Millimeter

Device Record Status

Public Device Record Key: 640c5df0-05d0-4cfc-92d9-b231decb822f
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: September 14, 2015