The following data is part of a premarket notification filed by Anatomics Pty Ltd with the FDA for Porestar Patient Specific Implant.
| Device ID | K171037 |
| 510k Number | K171037 |
| Device Name: | PoreStar Patient Specific Implant |
| Classification | Polymer, Ent Synthetic, Porous Polyethylene |
| Applicant | Anatomics Pty Ltd 23-27 Wellington St St Kilda, AU 3182 |
| Contact | Joanne Flatley |
| Correspondent | Nicholas Connell Brandwood Biomedical Level 8, 1 Chandos St St Leonards, AU 2065 |
| Product Code | JOF |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-06 |
| Decision Date | 2017-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349797001366 | K171037 | 000 |
| 09349797002547 | K171037 | 000 |
| 09349797002554 | K171037 | 000 |
| 09349797002561 | K171037 | 000 |
| 09349797001700 | K171037 | 000 |
| 09349797002387 | K171037 | 000 |
| 09349797000192 | K171037 | 000 |
| 09349797000208 | K171037 | 000 |
| 09349797000215 | K171037 | 000 |
| 09349797000222 | K171037 | 000 |
| 09349797000239 | K171037 | 000 |
| 09349797002530 | K171037 | 000 |