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FDA 510(k)

ORBITAL TISSUE EXPANDER (OTE)

K-Number: K060151 · 2006-08-08

ApplicantInnovia, LLC
Decision Date2006-08-08
Product CodeNFM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBITAL TISSUE EXPANDER (OTE) is the device name listed in this FDA 510(k) record. The listed applicant is Innovia, LLC. It received FDA 510(k) clearance on 2006-08-08 under 510(k) number K060151. The device is classified under product code NFM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBITAL TISSUE EXPANDER (OTE)?

ORBITAL TISSUE EXPANDER (OTE) is a medical device that received FDA 510(k) clearance on 2006-08-08. The listed applicant is Innovia, LLC. The 510(k) number is K060151.

When did ORBITAL TISSUE EXPANDER (OTE) receive FDA 510(k) clearance?

ORBITAL TISSUE EXPANDER (OTE) received FDA 510(k) clearance on 2006-08-08, under 510(k) number K060151.

Who is the listed applicant for ORBITAL TISSUE EXPANDER (OTE)?

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

What is the FDA product code for ORBITAL TISSUE EXPANDER (OTE)?

The FDA product code for ORBITAL TISSUE EXPANDER (OTE) is NFM.

Related Clinical Trials

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.

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Other records listing Innovia, 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.

K093783INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORTK090677INNOPORT LAPAROSCOPIC ACCESS DEVICE

Related Devices (Code: NFM)

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.

K010852OSMED TISSUE EXPANDERIop, Inc.

Official Source

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

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