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510(k) K921433

ATTIC DEFECT PLATE by Smith & Nephew Richards, Inc. — Product Code ETC

K921433 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "ATTIC DEFECT PLATE". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code ETC (Mold, Middle-Ear), a Class II device regulated under 21 CFR 874.3430. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
March 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mold, Middle-Ear
Device Class
Class II
Regulation Number
874.3430
Review Panel
EN
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)

FDA data resources