Data / Medical devices / United States / Integra LifeSciences Braintree Inc.
Integra LifeSciences Braintree Inc.: FDA-registered device maker in Braintree, MA, United States, 8 510(k) clearances
Integra LifeSciences Braintree Inc. is registered with the FDA (registration 3004170064) in Braintree, MA, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 7, 2017. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004170064
- Address
- 400b Wood Rd, Braintree, MA, United States, 02184
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer
- First device listed
- August 3, 2015
- Registered through
- 2026
- Brand names listed
- Durepair Dura Regeneration Matrix, PriMatrix, PriMatrix AG, Revize Collagen Matrix, Revize-X Collagen Matrix, SurgiMend -e Collagen Matrix, SurgiMend 1 Collagen Matrix, SurgiMend 2 Collagen Matrix and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | 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 |
|---|---|---|---|---|---|---|
| June 7, 2017 | K171357 | SurgiMend PRS Meshed, Revize-X | OXH | Substantially Equivalent | Integra Lifesciences Corporation (Owner of Tei Biosciences) | accessdata.fda.gov |
| February 16, 2017 | K162965 | SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction | FTM | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| November 2, 2016 | K161370 | Durepair Dura Regeneration Matrix | GXQ | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| February 22, 2016 | K153690 | PriMatrix Dermal Repair Scaffold | KGN | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| December 10, 2010 | K100261 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD | FRO | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| February 4, 2009 | K083898 | SURGIMEND | FTM | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| August 6, 2007 | K071807 | ORTHOMEND SOFT TISSUE MATRIX | FTM | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
| May 15, 2006 | K060989 | TISSUEMEND SOFT TISSUE REPAIR MATRIX | FTM | Substantially Equivalent | Tei Biosciences, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 23, 2023 | 92481 | Class II | Ongoing | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1 | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. | accessdata.fda.gov |
| June 15, 2017 | 78802 | Class II | Terminated | PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU wa | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical
- All makers of Dura Substitute
- All makers of Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated September 30, 2024. 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.