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Remex Spine Surgery Navigation System II

Remex Medical Corp.

Country / Region:Taiwan (TW)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Taiwan (TW)

Product code

OLO
21 CFR 882.4560

Predicate devices

4

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K233513
Device name
Remex Spine Surgery Navigation System II
Country / Region
Taiwan(TW)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-11-01
Decision date
2024-05-01
Submission type
Special
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

The Remex Spine Surgery Navigation System II is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Intended Use

The Remex Spine Surgery Navigation System II, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Device Description

The Remex Spine Surgery Navigation System II, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

Summary parsed at:2026-06-19 05:29:07 UTC

Predicate devices

4

K233513 references 4 predicate/reference devices

Cited as predicate

3

3 submissions cite K233513 as a predicate