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510(k) K050449

QUANTUM VERTEBRAL BODY REPLACEMENT by Quantum Orthopedics, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2005
Date Received
February 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
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)
  • K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM (March 13, 2006)
  • K040276 — QUANTUM CEMENT RESTRICTOR (April 30, 2004)

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