Product areas
FDA product code distribution
510(k) submissions
Latest clearance
Product codes
Cited as predicate
FDA product code distribution
4 total
Showing 1–4
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | OLO | Class 2 | 2025-09-25 |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | GEI | Class 2 | 2025-09-09 |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | GEI | Class 2 | 2025-04-15 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | OLO | Class 2 | 2025-03-21 |
Companies whose devices this company cited as predicates
3 manufacturers
Companies that cited this company's devices as predicates
No citing manufacturers yet
Other companies will appear here when they cite this company's devices as predicates