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510(k) K040454

BIOFILL BONE VOID FILLER by Scient'X — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2004
Date Received
February 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • K052367 — SCIENT'X CEMENT RESTRICTOR (October 5, 2005)
  • K050348 — CO VERTEBRAL BODY REPLACEMENT (May 27, 2005)
  • K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS (May 23, 2005)
  • K043001 — MX POLYAXIAL PEDICLE SCREW (December 1, 2004)
  • K042964 — MX MONOAXIAL PEDICLE SCREW (November 22, 2004)
  • K042317 — CERVICAL PLATE (September 24, 2004)
  • K040747 — ALADYN RIGID SPINE PLATE (June 17, 2004)

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