OviTex PRS (Long Term Resorbable) — Tela Bio (510(k) K214070)
OviTex PRS (Long Term Resorbable) — Tela Bio (510(k) K214070) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OviTex PRS (Long Term Resorbable); Applicant: Tela Bio; Clearance track: 510(k).
| Device name | OviTex PRS (Long Term Resorbable) |
|---|---|
| Applicant | Tela Bio |
| Clearance track | 510(k) |
| Submission number | K214070 |
| Decision | Substantially Equivalent |
| Decision date | 2023-03-21 |
| Date received | 2021-12-27 |
| Product code | FTM |
| Device class | 2 |
| Medical specialty | General, Plastic Surgery |
| Applicant location | PA, US |
| Source | openFDA device |
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