AccessGUDID - DEVICE: OptiMesh Multiplanar Expandable Interbody Fusion System (M7403100009)

GUDID

Device Identifier (DI) Information

Brand Name: OptiMesh Multiplanar Expandable Interbody Fusion System
Version or Model: 10-01-87
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 310-0009
Company Name: SPINEOLOGY INC.

Primary DI Number: M7403100009
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033014361 *Terms of Use

Device Description: Pin Introducer, 11g X 15cm Diamond

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?
58927	Orthopaedic prosthesis implantation positioning instrument, single-use	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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: 11 Gauge
Length: 15 Centimeter

Device Record Status

Public Device Record Key: 5c069847-e55a-4eda-93f0-af6b3b82fabc
Public Version Date: September 22, 2023
Public Version Number: 1
DI Record Publish Date: September 14, 2023