Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012669262

FEI Number

3012669262

Entity Name

ALAFAIR BIOSCIENCES, INC.

City/State/Country

Austin, TX, US

Establishment Address

6101 W. Courtyard Dr., Ste 1-225, Austin, TX 78730, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Alafair Biosciences, Inc. (Owner Number: 10052283)

Owner / Operator Contact Address

6101 West Courtyard Drive, Suite #1-225, Austin, TX 78730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200311

PMA Number

N/A

All Registered Proprietary Names

VersaCoat Nerve Protector VersaCoat Tendon Protector VersaWrap Nerve Protector VersaWrap Nerve Protector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2025-11-19
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2023-11-30
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2021-12-07
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-11-19
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2020-09-22
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2025-07-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2020-04-21

Official Correspondent

Sarah Mayes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alafair Biosciences, Inc.

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
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012669262. Last updated year: 2026. Please use registration number 3012669262 when referencing this establishment in official correspondence.