Manufacturer
Remex Medical Corp.Anatase Navi Disposable Instrument
Country / Region:Taiwan (TW)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241625
- Device name
- Anatase Navi Disposable Instrument
- Company
- Remex Medical Corp.
- Country / Region
- Taiwan(TW)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-06-06
- Decision date
- 2024-07-05
- 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 Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are 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 Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, are 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 Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Guiding awl is intended to support the surgeon to create an entry point before implanting the screw. The Spine pin with DRF-D and MIS LOC with DRF are both intended to fix the DRF on the vertebra by boned pins or the clamp. Once the DRF is fixed on the vertebra, the system can track the position of the patient's vertebra and instruments.
Summary parsed at:2026-06-19 05:33:42 UTC
Predicate devices
3—
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Not ingested
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Remex Spine Surgery Navigation System II
K241625 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241625 as a predicate
