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510(k) K801345

KAMPNER HINGED TOE PROSTHESIS by Biomedics — Product Code KWH

K801345 is an FDA 510(k) premarket notification submitted by Biomedics for the device "KAMPNER HINGED TOE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Biomedics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1980
Date Received
June 6, 1980
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 Biomedics

  • K992330 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (November 23, 1999)
  • K984583 — THE BIOPLATE SHUNT CONNECTOR (March 15, 1999)
  • K980983 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (June 9, 1998)
  • K972463 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (September 25, 1997)
  • K961976 — THE BIOPLATE FIXATION SYSTEM (August 16, 1996)
  • K953273 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM (September 29, 1995)
  • K943071 — THE TITANIUM FIXATION SYSTEM (January 6, 1995)
  • K844787 — BIOMETRIC TOTAL HIP SYSTEM (April 19, 1985)
  • K842687 — BIOMEDICS BLADDER SCANNER (April 8, 1985)

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)
  • K023086 — CLASSIC GREAT TOE IMPLANT (October 4, 2002)

FDA data resources