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510(k) K080537

L-VARLOCK by Kiscomedica S.A. — Product Code MAX

K080537 is an FDA 510(k) premarket notification submitted by Kiscomedica S.A. for the device "L-VARLOCK". The FDA issued a decision of Substantially Equivalent on June 30, 2008. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2008
Date Received
February 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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FDA data resources