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

Woodstock, GA, US

Acera Surgical, Inc. C/O Linda Braddon, PhD appears in FDA device records in Woodstock, GA. FDA records list 7 510(k) clearances between 2016-03-16 and 2025-06-20, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 7
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Acera Surgical, Inc. C/O Linda Braddon, PhD carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Acera Surgical, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 7 510(k) clearances for Acera Surgical, Inc. C/O Linda Braddon, PhD between 2016 and 2025. The busiest year on record is 2016, with 2. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Acera Surgical, Inc. C/O Linda Braddon, PhD, by decision year
Year	Clearances
2016	2
2017	2
2020	1
2023	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251224	Restrata Soft Tissue Reinforcement (STR)	OXF	Substantially Equivalent	2025-06-20
K223725	Restrata® MiniMatrix	QSZ	Substantially Equivalent	2023-05-18
K193583	Restrata®	QSZ	Substantially Equivalent	2020-09-25
K172603	Cerafix Dura Substitute	GXQ	Substantially Equivalent	2017-11-27
K170300	Restrata Wound Matrix	QSZ	Substantially Equivalent	2017-04-26
K161278	Cerafix Dura Substitute	GXQ	Substantially Equivalent	2016-08-08
K153613	Cerafix Dura Substitute	GXQ	Substantially Equivalent	2016-03-16

Registered establishments

FDA registered establishments for Acera Surgical, Inc. C/O Linda Braddon, PhD, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3012429393	3012429393	Acera Surgical, Inc. C/O Linda Braddon, PhD	7842 Hickory Flat Hwy Ste B, Woodstock, GA 30188 US	2026	GXQ OXF QSZ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1030-2022	Restrata, Part Number RWM1-2X2	Misprinted expiration date on the shelf-box	Class II	2022-03-21	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain