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510(k) K033046

SUBTALAR PEG IMPLANT by Nexa Orthopedics, Inc. — Product Code MJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Subtalar, Plug, Polymer
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Nexa Orthopedics, Inc.

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  • K070688 — NEXFIX COMPRESSION STAPLE (May 18, 2007)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)
  • K060071 — NEXA COMPRESSION SCREW (January 26, 2006)
  • K053408 — NEXA BONE PLATE AND SCREW SYSTEM (December 22, 2005)
  • K053394 — NEXA BONE SCREW SYSTEM (December 14, 2005)
  • K051740 — TAPERED COMPRESSION PIN (September 6, 2005)
  • K051406 — OSTEOCURE RESORBABLE BEAD KIT (August 1, 2005)
  • K032902 — SUBTALAR ARTHRORISIS IMPLANT (December 15, 2003)

Other clearances for product code MJW

  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)