Manufacturer
Remex Medical Corp.Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Country / Region:Taiwan (TW)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)
Device details
FDA 510(k) registration fields
- K number
- K220348
- Device name
- Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
- Company
- Remex Medical Corp.
- Country / Region
- Taiwan(TW)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-02-07
- Decision date
- 2022-07-14
- Submission type
- Traditional
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
3Anatase Spine Surgery Navigation System
Remex Spine Surgery Navigation System II
Anatase Navi Disposable Instrument
3 submissions cite K220348 as a predicate