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510(k) K060491

QUANTUM ANTERIOR CERVICAL PLATE SYSTEM by Quantum Orthopedics, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2006
Date Received
February 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Quantum Orthopedics, Inc.

  • K062004 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT (August 15, 2006)
  • K061576 — MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM (July 3, 2006)
  • K052641 — MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT (April 12, 2006)
  • K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT (July 7, 2005)
  • K040276 — QUANTUM CEMENT RESTRICTOR (April 30, 2004)

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