Manufacturer
Orthosoft Inc. (d/b/a) Zimmer CASROSA® Knee System
Orthosoft Inc. (d/b/a) Zimmer CAS
Country / Region:Canada (CA)Submission type:Special
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
- K242864
- Device name
- ROSA® Knee System
- Country / Region
- Canada(CA)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-09-20
- Decision date
- 2024-10-18
- Submission type
- Special
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
1Rosa® Knee System
1 submission cite K242864 as a predicate