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FDA 510(k)

IMMIX PLASTIFILM

K-Number: K032673 · 2003-10-02

ApplicantOsteobiologics, Inc.
Decision Date2003-10-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMMIX PLASTIFILM is the device name listed in this FDA 510(k) record. The listed applicant is Osteobiologics, Inc.. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032673. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMIX PLASTIFILM?

IMMIX PLASTIFILM is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Osteobiologics, Inc.. The 510(k) number is K032673.

When did IMMIX PLASTIFILM receive FDA 510(k) clearance?

IMMIX PLASTIFILM received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032673.

Who is the listed applicant for IMMIX PLASTIFILM?

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

What is the FDA product code for IMMIX PLASTIFILM?

The FDA product code for IMMIX PLASTIFILM is FTL.

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Other records listing Osteobiologics, Inc. 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.

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Related Devices (Code: FTL)

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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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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