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510(k) K053408

NEXA BONE PLATE AND SCREW SYSTEM by Nexa Orthopedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2005
Date Received
December 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Nexa Orthopedics, Inc.

  • K072710 — NEXFIX COMPRESSION PIN (November 8, 2007)
  • K071147 — NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM (July 20, 2007)
  • K070688 — NEXFIX COMPRESSION STAPLE (May 18, 2007)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)
  • K060071 — NEXA COMPRESSION SCREW (January 26, 2006)
  • K053394 — NEXA BONE SCREW SYSTEM (December 14, 2005)
  • K051740 — TAPERED COMPRESSION PIN (September 6, 2005)
  • K051406 — OSTEOCURE RESORBABLE BEAD KIT (August 1, 2005)
  • K033046 — SUBTALAR PEG IMPLANT (December 23, 2003)
  • K032902 — SUBTALAR ARTHRORISIS IMPLANT (December 15, 2003)

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