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Anatase Navi Disposable 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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241625
Device name
Anatase Navi Disposable Instrument
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

K241625 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K241625 as a predicate