K171037 is an FDA 510(k) clearance for the PoreStar Patient Specific Implant. This device is classified as a Polymer, Ent Synthetic, Porous Polyethylene (Class II - Special Controls, product code JOF).
Submitted by Anatomics Pty, Ltd. (St Kilda, AU). The FDA issued a Cleared decision on December 27, 2017, 265 days after receiving the submission on April 6, 2017.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K171037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2017 |
| Decision Date | December 27, 2017 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | JOF - Polymer, Ent Synthetic, Porous Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |