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510(k) K061208

LIFECELL DURAL SUBSTITUTE MATRIX by Lifecell Corp. — Product Code GXQ

K061208 is an FDA 510(k) premarket notification submitted by Lifecell Corp. for the device "LIFECELL DURAL SUBSTITUTE MATRIX". The FDA issued a decision of Substantially Equivalent on January 3, 2007. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Lifecell Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2007
Date Received
May 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
Review Panel
NE
Submission Type

Other clearances by Lifecell Corp.

  • K130817 — LTN - LAPAROSCOPIC SURGICAL MESH (April 17, 2013)
  • K112534 — LIFECELL TISSUE EXPANDER (August 10, 2012)
  • K121289 — LTM-LABAROSCOPIC SURGICAL MESH (August 3, 2012)
  • K082176 — LTM-BPS SURGICAL MESH (November 14, 2008)
  • K082103 — LTM WOUND DRESSING (October 8, 2008)
  • K080353 — LTM-T SURGICAL MESH (April 3, 2008)
  • K071986 — LTM-RC SURGICAL MESH (October 19, 2007)
  • K070560 — LRTM SURGICAL MESH (June 11, 2007)
  • K052735 — ALLOCRAFT DBM (December 28, 2005)

Other clearances for product code GXQ

  • K251191 — Collagen Dura Regeneration Membrane - Repair (November 18, 2025)
  • K250420 — Helios Dura Regeneration Matrix (May 14, 2025)
  • K223445 — ArtiFascia (August 10, 2023)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K172603 — Cerafix Dura Substitute (November 27, 2017)
  • K163456 — DuraGen Secure Dural Regeneration Matrix (January 6, 2017)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K161278 — Cerafix Dura Substitute (August 8, 2016)
  • K153613 — Cerafix Dura Substitute (March 16, 2016)

FDA data resources