JOF — Polymer, Ent Synthetic, Porous Polyethylene Class II
FDA product code JOF covers "Polymer, Ent Synthetic, Porous Polyethylene", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOF
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200532 | anatomics pty | StarPore | June 2, 2020 |
| K171037 | anatomics pty | PoreStar Patient Specific Implant | December 27, 2017 |
| K083621 | porex surgical | MEDPOR CUSTOMIZED SURGICAL IMPLANT | February 3, 2009 |
| K002629 | pillar surgical | SILMAX CONTOUR CARVING BLOCK IMPLANT | November 20, 2000 |
| K771727 | xomed | BIOSPONGE RECONSTRUCTION DISCS | September 26, 1977 |
| K771726 | xomed | BIOSPONGE STAPES PISTON | September 26, 1977 |