AccessGUDID - DEVICE: OptiMesh Multiplanar Expandable Interbody Fusion System (M7403100010)

GUDID

Device Identifier (DI) Information

Brand Name: OptiMesh Multiplanar Expandable Interbody Fusion System
Version or Model: 10-01-99
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 310-0010
Company Name: SPINEOLOGY INC.

Primary DI Number: M7403100010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: 8G x 19.3cm Pin Introducer Bevel

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
66937	Spinal intraoperative positioning/manipulation pin, single-use	A nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded; however, as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Needle Gauge: 8 Gauge
Length: 19.3 Centimeter

Device Record Status

Public Device Record Key: d75a2eb1-7013-4097-935b-96070712f913
Public Version Date: March 19, 2026
Public Version Number: 2
DI Record Publish Date: July 16, 2024