Manufacturer
Remex Medical Corp.Remex Spine Surgery Navigation System II
Country / Region:Taiwan (TW)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K233513
- Device name
- Remex Spine Surgery Navigation System II
- Company
- Remex Medical Corp.
- 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—
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Not ingested
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
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Not ingested
Anatase Spine Surgery Navigation System
K233513 references 4 predicate/reference devices
Cited as predicate
3Anatase Navi Disposable Instrument
Remex Spine Surgery Navigation Instrument
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
3 submissions cite K233513 as a predicate
