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510(k) K111069

OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT by Osteosymbionics, LLC — Product Code MNF

K111069 is an FDA 510(k) premarket notification submitted by Osteosymbionics, LLC for the device "OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT". The FDA issued a decision of Substantially Equivalent on September 22, 2011. The device falls under product code MNF (Implant, Temporal), a Class II device regulated under 21 CFR 878.3550. Osteosymbionics, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
April 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Temporal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Osteosymbionics, LLC

  • K133082 — OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE (May 20, 2014)
  • K121102 — OSTEOSYMBIONICS PEEK CRANIAL IMPLANT (August 8, 2012)
  • K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (December 10, 2007)

Other clearances for product code MNF

  • K002586 — MEDPOR PTERIONAL SURGICAL IMPLANT (November 17, 2000)

FDA data resources