Data / Medical devices / United States / Integra Lifesciences Corporation
Integra Lifesciences Corporation: FDA-registered device maker in Plainsboro, NJ, United States, 16 510(k) clearances and 3 PMA approvals
Integra Lifesciences Corporation is registered with the FDA (registration 1121308) in Plainsboro, NJ, United States. It lists 9 device types. The FDA files 16 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 6, 2017. 16 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1121308
- Address
- 105 and 109 MORGAN LANE, Plainsboro, NJ, United States, 08536
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- June 12, 2006
- Registered through
- 2026
- Brand names listed
- BioMend Absorbable Collagen Membrane, Biomend Extend Absorbable Collagen Membrane, CollaCote Absorbable Collagen Wound Dressing, CollaPlug Absorbable Collagen Wound Dressing, CollaTape Absorbable Collagen Wound Dressing, DURAGEN PLUS ADHESION BARRIER MATRIX, DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Collagen Based | LMF | 3 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Cuff, Nerve | JXI | 2 | Manufacturer | accessdata.fda.gov |
| Device, Dermal Replacement | MDD | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Dressing, Wound And Burn, Interactive | MGR | 3 | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Material, Dressing, Surgical, Polylactic Acid | LPG | 3 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2017 | K163457 | NeuraGen 3D Nerve Guide Matrix | JXI | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| June 15, 2012 | K120600 | DURAGEN SECURE DURAL REGNERATION MATRIX | GXQ | Substantially Equivalent | Integra Life Sciences | accessdata.fda.gov |
| February 9, 2012 | K113104 | INTEGRA WOUND MATRIX (THIN) | KGN | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 4, 2008 | K081635 | INTEGRA MESHED BILAYER WOUND MATRIX | KGN | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| October 10, 2007 | K072113 | INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 | KGN | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 23, 2007 | K072207 | DURAGEN XS DURAL REGENERATION MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| February 3, 2006 | K053655 | TENDON WRAP TENDON PROTECTOR | FTM | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| January 12, 2005 | K043427 | DURAGEN II DURAL REGENERATION MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 16, 2004 | K041620 | NEURA WRAP NERVE PROTECTOR | JXI | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| September 30, 2003 | K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| September 10, 2002 | K022127 | AVAGEN WOUND DRESSING | KGN | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 14, 2002 | K021792 | BILAYER MATRIX WOUND DRESSING | KGN | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| June 22, 2001 | K011168 | NEUROGEN NERVE GUIDE | JXI | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 26, 1999 | K992216 | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE | LYC | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 6, 1999 | K982180 | DURAGEN DURAL GRAFT MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 22, 1995 | K924408 | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE | LYC | Substantially Equivalent | Colla-Tec, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 1, 1996 | P900033 | INTEGRA DERMAL REGENERATION TEMPLATE | MGR | 109 | September 18, 2026 | accessdata.fda.gov |
| November 8, 1985 | P850010 | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | LMF | 113 | September 18, 2026 | accessdata.fda.gov |
| November 8, 1985 | P840062 | COLLACOTE(TM) | LPG | 94 | September 18, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 11, 2016 | 73689 | Class II | Terminated | Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer | Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750). | accessdata.fda.gov |
| March 28, 2014 | 68284 | Class II | Terminated | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various size | New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S). | accessdata.fda.gov |
| May 9, 2013 | 65406 | Class II | Terminated | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. | As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the pot | accessdata.fda.gov |
| March 28, 2013 | 64778 | Class II | Terminated | Dural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplie | Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. | accessdata.fda.gov |
| August 9, 2012 | 62978 | Class II | Terminated | Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system tha | T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it | accessdata.fda.gov |
| April 4, 2012 | 62138 | Class II | Terminated | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the vent | The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure". | accessdata.fda.gov |
| January 23, 2012 | 61131 | Not yet classified | Terminated | Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the TomoTherapy HiArt (Torno) System The Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation duri | Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree TomoTherapy arc. | accessdata.fda.gov |
| October 20, 2011 | 60836 | Not yet classified | Terminated | Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors | Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display. | accessdata.fda.gov |
| October 14, 2011 | 61093 | Not yet classified | Terminated | Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. | A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts, causing the stroke range of the tip to exceed it require | accessdata.fda.gov |
| October 7, 2011 | 60938 | Not yet classified | Terminated | Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placeme | Integra OS Osteoconductive Putty is labeled with incorrect storage conditions. | accessdata.fda.gov |
| July 2, 2010 | 56190 | Not yet classified | Terminated | Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10 | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. | accessdata.fda.gov |
| January 13, 2010 | 54253 | Not yet classified | Terminated | Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an | One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications. | accessdata.fda.gov |
| January 16, 2009 | 50899 | Not yet classified | Terminated | Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained. | accessdata.fda.gov |
| September 30, 2008 | 49561 | Not yet classified | Terminated | Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 Intended to open the UNI-Compression Plate olive, which crea | Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate | accessdata.fda.gov |
| July 2, 2008 | 48964 | Not yet classified | Terminated | Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm), Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA | Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010. | accessdata.fda.gov |
| December 16, 2002 | 25255 | Not yet classified | Terminated | External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A. | The check valve in the patient line may stick in the closed position. | accessdata.fda.gov |
Compare with other makers
- All makers of Dura Substitute
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Agent, Absorbable Hemostatic, Collagen Based
- All makers of Device, Dermal Replacement
- All makers of Dressing, Wound And Burn, Interactive
- All makers of Cuff, Nerve
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.