Duraseal Exact Spine Sealant System
by Integra Lifesciences Corporation
PMA P080013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP080013 | Date4 Sep 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Sealant, dural
- PMA Number
- FDA Product Code
- NQR
- Device Class
- Class III
- Advisory Committee
- Neurology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Duraseal Exact Spine Sealant System is a dural sealant indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure. It is manufactured by Integra Lifesciences Corporation and has received FDA PMA approval under number P080013.
The device is supplied as a sterile, single-use system intended for use in spinal surgical settings. It is not MRI conditional unless explicitly stated, and storage and handling should follow manufacturer guidelines. The product is classified as a Class III device under FDA regulations.
Other devices from Integra Lifesciences Corporation
Questions
AI-generated answers, 18 Sep 2026
What is the Duraseal Exact Spine Sealant System used for?
The Duraseal Exact Spine Sealant System is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure, based on the FDA approval documentation provided in the device data.
Who manufactures the Duraseal Exact Spine Sealant System?
The Duraseal Exact Spine Sealant System is manufactured by Integra Lifesciences Corporation, as stated in the manufacturer and applicant fields of the device data.
Is the Duraseal Exact Spine Sealant System a single-use device?
Yes, the Duraseal Exact Spine Sealant System is supplied as a sterile, single-use system, which is standard for surgical sealants of this type and implied by its clinical use in spinal dural repair.