IMPLANT, HINGE TOE, FLEX.— 510(k) K780132

Name: FDA 510(k) clearance K780132
Creator: U.S. Food and Drug Administration
Published: 1978-02-06

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K780132 for IMPLANT, HINGE TOE, FLEX., Substantially Equivalent on 1978-02-06. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1978-01-24
Decision date: 1978-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K153609 — RTS Flexible 1 MPJ Implant w/Grommets2016-09-08
K102601 — ORTHOFLEX ROD2011-01-14

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K843995 — TF-II HIP PROSTHESIS1985-04-23
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Data sourced from openFDA. This site is unofficial and independent of the FDA.