Restrata® MiniMatrix
Acera Surgical, Inc.
Acera Surgical, Inc. C/O Linda Braddon, PhD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012429393 | 3012429393 | Acera Surgical, Inc. C/O Linda Braddon, PhD | 1 | N | 2026-01-01 | 7842 Hickory Flat Hwy Ste B Woodstock GA US 30188 |
| 3027386220 | 3027386220 | Acera Surgical - Adie Road | 1 | N | 2026-01-01 | 11825 Adie Road Maryland Heights MO US 63043 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 192595 | 1074765444 | K251224 | Restrata Soft Tissue Reinforcement (STR) | OXF | 2025-06-20 |
| 317737 | 1187876924 | K223725 | Restrata® MiniMatrix | QSZ | 2023-05-18 |
| 192595 | 1885604815 | K193583 | Restrata® | QSZ | 2020-09-25 |
| 192595 | 1329966713 | K172603 | Cerafix Dura Substitute | GXQ | 2017-11-27 |
| 192595 | 1147474722 | K170300 | Restrata Wound Matrix | QSZ | 2017-04-26 |
| 192595 | 1556042683 | K161278 | Cerafix Dura Substitute | GXQ | 2016-08-08 |
| 192595 | 1989017394 | K153613 | Cerafix Dura Substitute | GXQ | 2016-03-16 |
Product Codes Associated With Registrations#
PMN#
Restrata®
Acera Surgical, Inc.
Cerafix Dura Substitute
Acera Surgical, Inc.
Restrata Wound Matrix
Acera Surgical, Inc.
Cerafix Dura Substitute
ACERA SURGICAL, INC.
Cerafix Dura Substitute
ACERA SURGICAL, INC.
GUDID#
Restrata(R) - Restrata(R) is a sterile, single use device. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix.
2026-04-15
Restrata Meshed - Restrata is a sterile, single use device.
2026-04-15
Restrata MiniMatrix - RMINI-100
2023-06-29
Restrata MiniMatrix - RMINI-250
2023-06-29
Restrata MiniMatrix - RMINI-500
2023-06-29
Restrata MiniMatrix - RMINI-1000
2023-06-29
Restrata MiniMatrix - RMINI-2000
2023-06-29
Restrata Meshed - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Wound Matrix - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Wound Matrix - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Wound Matrix - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Meshed - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Meshed - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Meshed - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata Meshed - The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
2022-04-21
Restrata™ Wound Matrix - The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
2017-07-24
CovoraTM - CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
2019-10-04
CovoraTM - CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
2019-10-04
CovoraTM - CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
2019-10-04
Restrata(R) - Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.
2019-05-20
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable,nonfriable, porous polymer matrix.
2017-03-07
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
2017-03-07
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
2017-03-07
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
2017-03-07
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
2017-03-07
Cerafix® Dura Substitute - Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
2017-03-07
Restrata™ Wound Matrix - The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
2017-07-24
Restrata™ Wound Matrix - The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
2017-07-24
Restrata™ Wound Matrix - The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
2017-07-24
Restrata™ Wound Matrix - The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
2017-07-24