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510(k) K820813

LESSER METATARSAL PHALANG. JOINT PROSTH by Sutter Biomedical, Inc. — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1982
Date Received
March 23, 1982
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 Biomedical, Inc.

  • K875249 — SUTTER PHALANGEAL CAP (February 3, 1988)
  • K870200 — SUTTER FINGER JOINT PROSTHESIS (October 9, 1987)
  • K861983 — SUTTER LESSER METATARSAL CAP (September 8, 1986)
  • K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT (April 25, 1985)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)
  • K830649 — SUTTER CPM 2000 (March 17, 1983)
  • K823539 — SUTTER CPM (January 14, 1983)
  • K820083 — SUTTER CPM (January 28, 1982)
  • K812691 — SILICONE IMPLANTS (November 16, 1981)
  • K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT (October 14, 1981)

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)