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510(k) K905795

SGARLATO FLEXIBLE HINGE TOE IMPLANT by Sgarlato Laboratories, Inc. — Product Code KWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1991
Date Received
December 27, 1990
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 Sgarlato Laboratories, Inc.

  • K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP (March 30, 2005)
  • K990101 — PAIN CONTROL INFUSION PUMP (March 19, 1999)
  • K982931 — THREADED FIXATION PIN (October 21, 1998)
  • K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (January 26, 1994)
  • K926237 — O'BRIEN GONIOMETER (August 2, 1993)
  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)
  • K884739 — SGARLATO LESSER TOE IMPLANT (May 18, 1989)

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)