Home / 510(k) Clearances / K943354

510(k) K943354

SUTTER HAMMERTOE JOINT PROSTHESIS by Sutter Corp. — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1995
Date Received
July 12, 1994
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 Sutter Corp.

  • K945221 — SUTTER MODEL 6000 HAND CPM DEVICE (February 27, 1995)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)
  • K924654 — FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT (February 22, 1993)
  • K914860 — SUTTER MODEL 10000 LEG CPM DEVICE (January 8, 1992)
  • K902707 — MODEL 9000 AT ANKLE CPM DEVICE (July 25, 1990)
  • K890607 — SUTTER HOSPITAL CPM (February 27, 1989)

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)