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510(k) K023086

CLASSIC GREAT TOE IMPLANT by Nexa Orthopedics, Inc. — Product Code KWH

K023086 is an FDA 510(k) premarket notification submitted by Nexa Orthopedics, Inc. for the device "CLASSIC GREAT TOE IMPLANT". The FDA issued a decision of Substantially Equivalent on October 4, 2002. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Nexa Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2002
Date Received
September 17, 2002
Clearance Type
Special
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.

  • 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)
  • 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

  • K191966 — NewPrim System (February 13, 2020)
  • 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)
  • K994326 — ASCENT KNEE SYSTEM (January 7, 2000)

FDA data resources