Acera Surgical, Inc. C/O Linda Braddon, PhD

FDA Device Registration & Listing · Woodstock, GA, US · Registration 3012429393

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012429393
FEI Number
3012429393
Entity Name
Acera Surgical, Inc. C/O Linda Braddon, PhD
City/State/Country
Woodstock, GA, US
Establishment Address
7842 Hickory Flat Hwy Ste B, Woodstock, GA 30188, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Acera Surgical, Inc. (Owner Number: 10051479)
Owner / Operator Contact Address
1650 Des Peres Rd, Ste 120, Saint Louis, MO 63131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251224
PMA Number
N/A

All Registered Proprietary Names

Cerafix® Dura Substitute

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2018-05-22
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2020-11-04
GXQ Dura Substitute Neurology Class 2 882.5910 2016-03-23
OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2025-11-17

Official Correspondent

Lily Jeng

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Acera Surgical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027386220 Acera Surgical - Adie Road Maryland Heights, MO, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012429393. Last updated year: 2026. Please use registration number 3012429393 when referencing this establishment in official correspondence.
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