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FDA 510(k)

OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT

K-Number: K111069 · 2011-09-22

ApplicantOsteosymbionics, LLC
Decision Date2011-09-22
Product CodeMNF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Osteosymbionics, LLC. It received FDA 510(k) clearance on 2011-09-22 under 510(k) number K111069. The device is classified under product code MNF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT?

OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Osteosymbionics, LLC. The 510(k) number is K111069.

When did OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT receive FDA 510(k) clearance?

OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT received FDA 510(k) clearance on 2011-09-22, under 510(k) number K111069.

Who is the listed applicant for OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT?

The FDA 510(k) record lists Osteosymbionics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT?

The FDA product code for OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT is MNF.

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Other records listing Osteosymbionics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121102OSTEOSYMBIONICS PEEK CRANIAL IMPLANTK072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT

Related Devices (Code: MNF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002586MEDPOR PTERIONAL SURGICAL IMPLANTPorex Surgical Products Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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