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Remex Spine Surgery Navigation Instrument

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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243560
Device name
Remex Spine Surgery Navigation Instrument
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

2

K243560 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K243560 as a predicate