AccessGUDID - DEVICE: 3DP Lumbar Interbody (M719GLL1050)

GUDID

Device Identifier (DI) Information

Brand Name: 3DP Lumbar Interbody
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GLL105
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GLL1050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: Modular Hudson Connect T-Handle

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?
48165	Lumbar total intervertebral disc prosthesis	An implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component between. It may facilitate some degree of motion and is typically made of metal and/or synthetic polymer materials. This is the complete prosthesis assembly, not individual components.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar
MQP	Spinal Vertebral Body Replacement Device

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
No Device Sizes

Device Record Status

Public Device Record Key: 8c9f4f2d-a57a-4d08-a40b-379506af7750
Public Version Date: November 07, 2024
Public Version Number: 1
DI Record Publish Date: October 30, 2024