AccessGUDID - DEVICE: 3DP Lumbar Interbody System (M719GLL108L10150)

GUDID

Device Identifier (DI) Information

Brand Name: 3DP Lumbar Interbody System
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GLL108-L1015
Company Name: Genesys Orthopedics Systems LLC

Primary DI Number: M719GLL108L10150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017921066 *Terms of Use

Device Description: LLIF Torpedo Trial, Large 10mm x 15°

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?
61247	Orthopaedic cement restrictor sizer	A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
MQP	Spinal Vertebral Body Replacement Device
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
No Device Sizes

Device Record Status

Public Device Record Key: 1ac7d31c-6517-4679-8829-234a3e982c76
Public Version Date: January 22, 2025
Public Version Number: 1
DI Record Publish Date: January 14, 2025