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510(k) K053394

NEXA BONE SCREW SYSTEM by Nexa Orthopedics, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2005
Date Received
December 6, 2005
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 Nexa Orthopedics, Inc.

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  • 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)
  • K053408 — NEXA BONE PLATE AND SCREW SYSTEM (December 22, 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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