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FDA 510(k)

AVANTGARDE

K-Number: K951847 · 1995-05-12

ApplicantOtto Bock Orthopedic Industry, Inc.
Decision Date1995-05-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AVANTGARDE is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Orthopedic Industry, Inc.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K951847. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANTGARDE?

AVANTGARDE is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Otto Bock Orthopedic Industry, Inc.. The 510(k) number is K951847.

When did AVANTGARDE receive FDA 510(k) clearance?

AVANTGARDE received FDA 510(k) clearance on 1995-05-12, under 510(k) number K951847.

Who is the listed applicant for AVANTGARDE?

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

What is the FDA product code for AVANTGARDE?

The FDA product code for AVANTGARDE is IOR.

Related Clinical Trials

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Other records listing Otto Bock Orthopedic Industry, 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: IOR)

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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