Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015194982

FEI Number

3015194982

Entity Name

SURGICAL INNOVATION ASSOCIATES, INC.

City/State/Country

Chicago, IL, US

Establishment Address

445 W Erie St, Suite 111, Chicago, IL 60654, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Integra LifeSciences Corporation (Owner Number: 9004007)

Owner / Operator Contact Address

1100 Campus Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181094

PMA Number

N/A

All Registered Proprietary Names

DuraSorb Monofilament Mesh

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	2023-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013505638	REBOUND THERAPEUTICS, CORPORATION	Irvine, CA, US
3006697299	INTEGRA LIFESCIENCES (IRELAND) LIMITED	SRAGH TULLAMORE Offaly, IE
2648988	INTEGRA NEUROSCIENCES	ANASCO, PR, US
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015194982. Last updated year: 2026. Please use registration number 3015194982 when referencing this establishment in official correspondence.