Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007321028

FEI Number

3007321028

Entity Name

Aroa Biosurgery Ltd

City/State/Country

Airport Oaks Auckland, NZ

Establishment Address

2 Kingsford Smith Place, Airport Oaks Auckland 2022, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aroa Biosurgery Ltd (Owner Number: 10028943)

Owner / Operator Contact Address

2 Kingsford Smith Place, Airport Oaks, NZ-AUK 2022, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153632

PMA Number

N/A

All Registered Proprietary Names

OviTex® PRS Myriad Morcells Myriad Morcells Fine Endoform Dental Membrane OviTex® Reinforced Tissue Matrix Endoform Natural Restorative Bioscaffold Myriad Meshed Endoform Antimicrobial Restorative Bioscaffold OviTex® Reinforced Tissue Matrix OviTex® Reinforced Tissue Matrix OviTex® Reinforced Tissue Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-04-15
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-04-15
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-03-31
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2024-07-17
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2024-07-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2018-12-04
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-12-04
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2010-02-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-02-14
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-11-17
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-11-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2016-04-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2016-06-21
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2016-06-21

Official Correspondent

Stacey Spies

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Aroa Biosurgery Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007321028. Last updated year: 2026. Please use registration number 3007321028 when referencing this establishment in official correspondence.