Data / Medical devices / United States / Acera Surgical, Inc. C/O Linda Braddon, PhD
Acera Surgical, Inc. C/O Linda Braddon, PhD: FDA-registered device maker in Woodstock, GA, United States, 6 510(k) clearances
Acera Surgical, Inc. C/O Linda Braddon, PhD is registered with the FDA (registration 3012429393) in Woodstock, GA, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 20, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012429393
- Address
- 7842 Hickory Flat Hwy Ste B, Woodstock, GA, United States, 30188
- Owner or operator
- Acera Surgical, Inc. (10051479)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 23, 2016
- Registered through
- 2026
- Brand names listed
- Cerafix Dura Substitute, Cerafix® Dura Substitute
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | OXF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 20, 2025 | K251224 | Restrata Soft Tissue Reinforcement (STR) | OXF | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
| September 25, 2020 | K193583 | Restrata® | QSZ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
| November 27, 2017 | K172603 | Cerafix Dura Substitute | GXQ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
| April 26, 2017 | K170300 | Restrata Wound Matrix | QSZ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
| August 8, 2016 | K161278 | Cerafix Dura Substitute | GXQ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
| March 16, 2016 | K153613 | Cerafix Dura Substitute | GXQ | Substantially Equivalent | Acera Surgical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 21, 2022 | 89919 | Class II | Terminated | Restrata, Part Number RWM1-2X2 | Misprinted expiration date on the shelf-box | accessdata.fda.gov |
Compare with other makers
- All makers of Absorbable Synthetic Wound Dressing
- All makers of Dura Substitute
- All makers of Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Updated June 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.