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FDA 510(k)

MECRON(R) ACETABULAR NETS TM

K-Number: K820619 · 1982-05-14

ApplicantSerrano Intl.
Decision Date1982-05-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MECRON(R) ACETABULAR NETS TM is the device name listed in this FDA 510(k) record. The listed applicant is Serrano Intl.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K820619. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECRON(R) ACETABULAR NETS TM?

MECRON(R) ACETABULAR NETS TM is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Serrano Intl.. The 510(k) number is K820619.

When did MECRON(R) ACETABULAR NETS TM receive FDA 510(k) clearance?

MECRON(R) ACETABULAR NETS TM received FDA 510(k) clearance on 1982-05-14, under 510(k) number K820619.

Who is the listed applicant for MECRON(R) ACETABULAR NETS TM?

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

What is the FDA product code for MECRON(R) ACETABULAR NETS TM?

The FDA product code for MECRON(R) ACETABULAR NETS TM is FTM.

Related Clinical Trials

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Other records listing Serrano Intl. 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.

K851409UNILOC TOTAL HIP PROSTHESISK820899MECRON VOORHOEVE TITANIUM SHEATHK820852MECRON CONCAVEX FLEXIBLE INTRAMEDULLARYK810497BONE FIXACTION SCREWK810205MECRON CANCELLOUS CANNULATED BONE SCREWS

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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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