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510(k) K952697

TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM by Smith & Nephew Richards, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1995
Date Received
June 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Smith & Nephew Richards, Inc.

  • K965224 — EMPOWER ANTERIOR DIRECT SCREWS (May 8, 1997)
  • K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (January 27, 1997)
  • K960444 — FINN ROD TO ROD CONNECTOR (January 24, 1997)
  • K964163 — TRIMAX NAIL SYSTEM (December 27, 1996)
  • K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT (December 5, 1996)
  • K963486 — REVISION HIP SYSTEM (November 27, 1996)
  • K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS (September 17, 1996)
  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
  • K962137 — GENESIS II CONSTRAINED SYSTEM (August 2, 1996)
  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)

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