Manufacturer
Remex Medical Corp.Remex Spine Surgery Navigation 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
- K243560
- Device name
- Remex Spine Surgery Navigation Instrument
- Company
- Remex Medical Corp.
- Country / Region
- Taiwan(TW)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-11-18
- Decision date
- 2024-12-13
- 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 instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). 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 spine 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, with the lumbar region.
Intended Use
The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). 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 spine 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, with the lumbar region.
Device Description
The Remex Spine Surgery Navigation Instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle. 1. Nav Awl: The subject device is intended to support the surgeon to create an entry point before implanting the screw. 2. Nav Drill Guide: The subject device is intended to assist in drilling holes to a desired depth and ensuring proper orientation. 3. Nav Tap: The subject device is intended to create screw threads. 4. Nav Screwdriver: The subject device is intended to driver the screw into the vertebra. Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap or Nav Screwdriver for navigation tracking purpose.
Summary parsed at:2026-06-19 05:35:56 UTC
Predicate devices
2Anatase Spine Surgery Navigation System
Remex Spine Surgery Navigation System II
K243560 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K243560 as a predicate
