SGARLATO LESSER TOE IMPLANT— 510(k) K884739

Name: FDA 510(k) clearance K884739
Creator: U.S. Food and Drug Administration
Published: 1989-05-18

Substantially Equivalent

Sgarlato Laboratories, Inc.

FDA 510(k) clearance K884739 for SGARLATO LESSER TOE IMPLANT, Substantially Equivalent on 1989-05-18. Applicant: Sgarlato Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Sgarlato Laboratories, Inc.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1988-11-14
Decision date: 1989-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWH

view all

K191966 — NewPrim System2020-02-13
K190136 — Fusion Silastic System2019-10-21
K173491 — RTS Lesser MTP Implant System2018-02-23
K153609 — RTS Flexible 1 MPJ Implant w/Grommets2016-09-08
K102601 — ORTHOFLEX ROD2011-01-14

More clearances from Sgarlato Laboratories, Inc.

view all

K043204 — SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP2005-03-30
K990101 — PAIN CONTROL INFUSION PUMP1999-03-19
K982931 — THREADED FIXATION PIN1998-10-21
K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE1994-01-26
K926237 — O'BRIEN GONIOMETER1993-08-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.