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510(k) K052641

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2006
Date Received
September 26, 2005
Clearance Type
Special
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)
  • K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM (March 13, 2006)
  • K050449 — QUANTUM VERTEBRAL BODY REPLACEMENT (July 7, 2005)
  • K040276 — QUANTUM CEMENT RESTRICTOR (April 30, 2004)

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