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510(k) K981194

FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT by Nexa Orthopedics, Inc. — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1998
Date Received
April 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3720
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)
  • K033046 — SUBTALAR PEG IMPLANT (December 23, 2003)

Other clearances for product code KWH

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  • K190136 — Fusion Silastic System (October 21, 2019)
  • K173491 — RTS Lesser MTP Implant System (February 23, 2018)
  • K153609 — RTS Flexible 1 MPJ Implant w/Grommets (September 8, 2016)
  • K102601 — ORTHOFLEX ROD (January 14, 2011)
  • K023531 — LESSER METATARSAL PHALANGEAL JOINT IMPLANT (January 17, 2003)
  • K022887 — INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 26, 2002)
  • K022886 — METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (November 25, 2002)
  • K023562 — MODIFICATION TO CLASSIC GREAT TOE IMPLANT (November 13, 2002)
  • K023086 — CLASSIC GREAT TOE IMPLANT (October 4, 2002)