OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT— 510(k) K111069

Name: FDA 510(k) clearance K111069
Creator: U.S. Food and Drug Administration
Published: 2011-09-22

Substantially Equivalent

Osteosymbionics, LLC

FDA 510(k) clearance K111069 for OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT, Substantially Equivalent on 2011-09-22. Applicant: Osteosymbionics, LLC. Device class: 2.

Clearance details

Applicant: Osteosymbionics, LLC
Product code: Code MNF
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2011-04-18
Decision date: 2011-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNF

view all

K002586 — MEDPOR PTERIONAL SURGICAL IMPLANT2000-11-17

More clearances from Osteosymbionics, LLC

view all

K133082 — OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE2014-05-20
K121102 — OSTEOSYMBIONICS PEEK CRANIAL IMPLANT2012-08-08
K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT2007-12-10

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