Acera Surgical, Inc.
Medical device manufacturer in St. Louis, MO.
7510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR)OXF · Traditional | 06/20/2025SE |
| K223725 | Restrata® MiniMatrixQSZ · Traditional | 05/18/2023SE |
| K193583 | Restrata®QSZ · Special | 09/25/2020SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | 11/27/2017SE |
| K170300 | Restrata Wound MatrixQSZ · Traditional | 04/26/2017SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | 03/16/2016SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1030-2022 Class II | Restrata, Part Number RWM1-2X2Misprinted expiration date on the shelf-box | 03/21/2022Terminated |