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FDA 510(k)

ORTHOSISES DEVICES

K-Number: K780225 · 1978-02-24

ApplicantBiomet, Inc.
Decision Date1978-02-24
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOSISES DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1978-02-24 under 510(k) number K780225. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSISES DEVICES?

ORTHOSISES DEVICES is a medical device that received FDA 510(k) clearance on 1978-02-24. The listed applicant is Biomet, Inc.. The 510(k) number is K780225.

When did ORTHOSISES DEVICES receive FDA 510(k) clearance?

ORTHOSISES DEVICES received FDA 510(k) clearance on 1978-02-24, under 510(k) number K780225.

Who is the listed applicant for ORTHOSISES DEVICES?

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

What is the FDA product code for ORTHOSISES DEVICES?

The FDA product code for ORTHOSISES DEVICES is IQI.

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Other records listing Biomet, 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: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, 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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