Manufacturer
Naviswiss AGNaviswiss Knee
Country / Region:Switzerland (CH)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K223351
- Device name
- Naviswiss Knee
- Company
- Naviswiss AG
- Country / Region
- Switzerland(CH)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-11-02
- Decision date
- 2023-01-31
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Knee SurgeryNavigation System
- Primary application
- Knee Surgery
- Classification source
- AI classified
Indications for Use
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
Intended Use
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
Summary parsed at:2026-06-19 05:41:41 UTC
Predicate devices
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Cited as predicate
0No later 510(k)s cite this device yet
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