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510(k) K042317

CERVICAL PLATE by Scient'X — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
August 26, 2004
Clearance Type
Special
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 Scient'X

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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)
  • K040747 — ALADYN RIGID SPINE PLATE (June 17, 2004)
  • K040454 — BIOFILL BONE VOID FILLER (May 7, 2004)

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