INTEGRA LIFESCIENCES CORPORATION

FDA Device Registration & Listing · PLAINSBORO, NJ, US · Registration 1121308

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1121308
FEI Number
1121308
Entity Name
INTEGRA LIFESCIENCES CORPORATION
City/State/Country
PLAINSBORO, NJ, US
Establishment Address
105 and 109 MORGAN LANE, PLAINSBORO, NJ 08536, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072207
PMA Number
N/A

All Registered Proprietary Names

HeliTape Absorbable Collagen Wound Dressing CollaPlug Absorbable Collagen Wound Dressing HeliCote Absorbable Collagen Wound Dressing HeliPlug Absorbable Collagen Wound Dressing OraTape Absorbable Collagen Wound Dressing OraPlug Absorbable Collagen Wound Dressing CollaCote Absorbable Collagen Wound Dressing CollaTape Absorbable Collagen Wound Dressing NeuraWrap Nerve Protector INTEGRA Flowable Wound Matrix OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane DuraGen Dural Graft Matrix INTEGRA Wound Matrix (Thin) DuraGen Secure Dural Regeneration Matrix Suturable DuraGen Dural Regenration Matrix INTEGRA Wound Matrix INTEGRA Matrix Wound Dressing Integra Meshed Bilayer Wound Matrix NeuraGen 3D Integra Dermal Regeneration Template Single Layer Integra Dermal Regeneration Template Single Layer Thin Integra Meshed Dermal Regeneration Template (OUS) DuraGen Plus Dural Regeneration Matrix DuraGen Dural Graft Matrix DuraGen Secure Dural Regeneration Matrix DURAGEN PLUS ADHESION BARRIER MATRIX SUTURABLE DURAGEN DURAL REGENERATION METRIX DuraGen XS Dural Regeneration Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LPG Material, Dressing, Surgical, Polylactic Acid Unknown Class 3 N/A 2007-11-30
JXI Cuff, Nerve Neurology Class 2 882.5275 2007-11-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2007-11-30
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2007-11-30
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2012-02-21
GXQ Dura Substitute Neurology Class 2 882.5910 2012-11-08
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2007-11-30
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2008-12-23
JXI Cuff, Nerve Neurology Class 2 882.5275 2020-01-29
MDD Device, Dermal Replacement Unknown Class 3 N/A 2017-04-20
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30
GXQ Dura Substitute Neurology Class 2 882.5910 2017-05-08
GXQ Dura Substitute Neurology Class 2 882.5910 2007-11-30

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
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K112888 Kensey Nash Corporation MESO WOUND MATRIX 2012-02-10
K040211 Collagen Matrix, Inc. MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING 2004-02-27
K052493 Steiner Laboratories SOCKET GRAFT 2006-06-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1121308. Last updated year: 2026. Please use registration number 1121308 when referencing this establishment in official correspondence.
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