AccessGUDID - DEVICE: DUALX LLIF 12-15MM x 0 DEG x 45MM (B707128310050170)

GUDID

Device Identifier (DI) Information

Brand Name: DUALX LLIF 12-15MM x 0 DEG x 45MM
Version or Model: 12831005017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMPLIFY SURGICAL, INC.

Primary DI Number: B707128310050170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081021000 *Terms of Use

Device Description: LLIF IMPLANT - 0° x 22MM IMPLANTS Lordosis & Heights: 12-15mm x 0° x 45mm Collapsed Width (mm): 13.34 Expanded Width (mm): 22 Collapsed Height (mm): 12.5 Expanded Height (mm): 15.5 Collapsed Length (mm): 53.76 Expanded Length (mm): 46.8

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":	Yes
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?
38161	Metallic 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 metal [e.g., titanium (Ti)] 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 [?]
K181397	000

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
No Device Sizes

Device Record Status

Public Device Record Key: a44d695e-4c6c-4606-969f-f4f7c22fb9b0
Public Version Date: May 21, 2025
Public Version Number: 5
DI Record Publish Date: July 25, 2019