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FDA 510(k)

BIOPRO HEMI-EDGE TOE SYSTEM

K-Number: K121973 · 2012-10-30

ApplicantBiopro, Inc.
Decision Date2012-10-30
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO HEMI-EDGE TOE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 2012-10-30 under 510(k) number K121973. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO HEMI-EDGE TOE SYSTEM?

BIOPRO HEMI-EDGE TOE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-30. The listed applicant is Biopro, Inc.. The 510(k) number is K121973.

When did BIOPRO HEMI-EDGE TOE SYSTEM receive FDA 510(k) clearance?

BIOPRO HEMI-EDGE TOE SYSTEM received FDA 510(k) clearance on 2012-10-30, under 510(k) number K121973.

Who is the listed applicant for BIOPRO HEMI-EDGE TOE SYSTEM?

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

What is the FDA product code for BIOPRO HEMI-EDGE TOE SYSTEM?

The FDA product code for BIOPRO HEMI-EDGE TOE SYSTEM is KWD.

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Other records listing Biopro, Inc. as applicant

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Related Devices (Code: KWD)

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

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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