Fixate Tissue Band

FDA 510(k) K113400 · Anulex Technologies, Inc.

Substantially Equivalent

510(k) numberK113400

Submission

Device name
Fixate Tissue Band
Applicant
Anulex Technologies, Inc.
Minnetonka, MN, US
Received
November 17, 2011
Decision date
December 16, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5880
Specialty
Neurology
Implant
Yes

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More from Stimwave Technologies Incorporated

510(k)DeviceDecision
K121356Micro/Mini N-Pk(H) Bone AnchorMBI · Traditional 11/09/2012SE
K121354Micro/Mini N-Pk(F) Bone AnchorMBI · Traditional 11/09/2012SE
K113805Fixate Tissue BandGZB · Traditional 02/23/2012SE
K112849Fixate Tissue BandGZB · Special 10/27/2011SE
K111462Fixate Tissue BandGZB · Traditional 09/08/2011SE
K100572Versaclose, Model VC-200-01GAT · Special 03/17/2010SE
K091432Xclose Tissue Repair System, Model XC-200-01GAT · Special 06/12/2009SE
K082729Rimclose Bone AnchorMBI · Traditional 12/19/2008SE
K062307Xclose Tissue Repair System, Model SRSGAT · Special 09/01/2006SE
K061386Anchor Band Suturing System, Model Sr-AbGAT · Traditional 07/05/2006SE

Questions and answers

When was Fixate Tissue Band cleared by the FDA?

Fixate Tissue Band (K113400) received a 510(k) decision of Substantially Equivalent on December 16, 2011, 29 days after the submission was received.

What is the product code of K113400?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.