JOF
6 FDA 510(k) clearances · Product code
89 daysmedian time to decision
265 days90th percentile
6clearances measured
FDA profile
- Official device name
- Polymer, Ent Synthetic, Porous Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- Flags
- Implant
- Adverse events (MAUDE)
- 1992: 1 · 2008: 3 · 2009: 4 · 2010: 15 · 2023: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| StarPore (K200532) | Anatomics Pty, Ltd. | 2020-06-02 |
| PoreStar Patient Specific Implant (K171037) | Anatomics Pty, Ltd. | 2017-12-27 |
| MEDPOR CUSTOMIZED SURGICAL IMPLANT (K083621) | Porex Surgical, Inc. | 2009-02-03 |
| SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) | Pillar Surgical, Inc. | 2000-11-20 |
| BIOSPONGE STAPES PISTON (K771726) | Xomed, Inc. | 1977-09-26 |
| BIOSPONGE RECONSTRUCTION DISCS (K771727) | Xomed, Inc. | 1977-09-26 |
Track JOF automatically
Every clearance here is in the API, with alerts when new ones post.