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FDA 510(k)

STERILE BUTTON PLATE

K-Number: K010121 · 2001-02-09

ApplicantSynthes (Usa)
Decision Date2001-02-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERILE BUTTON PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2001-02-09 under 510(k) number K010121. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE BUTTON PLATE?

STERILE BUTTON PLATE is a medical device that received FDA 510(k) clearance on 2001-02-09. The listed applicant is Synthes (Usa). The 510(k) number is K010121.

When did STERILE BUTTON PLATE receive FDA 510(k) clearance?

STERILE BUTTON PLATE received FDA 510(k) clearance on 2001-02-09, under 510(k) number K010121.

Who is the listed applicant for STERILE BUTTON PLATE?

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

What is the FDA product code for STERILE BUTTON PLATE?

The FDA product code for STERILE BUTTON PLATE is MBI.

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Other records listing Synthes (Usa) 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: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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