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FDA 510(k)

SpinMedix Absorbable Fibrous Membrane

K-Number: K222220 · 2023-07-06

ApplicantCelestray Biotech Company, LLC.,
Decision Date2023-07-06
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SpinMedix Absorbable Fibrous Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Celestray Biotech Company, LLC.,. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K222220. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpinMedix Absorbable Fibrous Membrane?

SpinMedix Absorbable Fibrous Membrane is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Celestray Biotech Company, LLC.,. The 510(k) number is K222220.

When did SpinMedix Absorbable Fibrous Membrane receive FDA 510(k) clearance?

SpinMedix Absorbable Fibrous Membrane received FDA 510(k) clearance on 2023-07-06, under 510(k) number K222220.

Who is the listed applicant for SpinMedix Absorbable Fibrous Membrane?

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

What is the FDA product code for SpinMedix Absorbable Fibrous Membrane?

The FDA product code for SpinMedix Absorbable Fibrous Membrane is OWW.

Other records listing Celestray Biotech Company, 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.

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Related Devices (Code: OWW)

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

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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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