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510(k) K083626

DISTRACTABLE WAVE CAGE by Advanced Medical Technology, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2009
Date Received
December 8, 2008
Clearance Type
Special
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.

Other clearances by Advanced Medical Technology, Inc.

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  • K854225 — ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS (December 27, 1985)
  • K852997 — RAPI - STAPH (August 19, 1985)
  • K853187 — ACRIDINE ORANGE FLUORESCENT STAIN (August 13, 1985)
  • K853081 — AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (August 13, 1985)

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