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FDA 510(k)

PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260

K-Number: K003659 · 2001-02-20

ApplicantBionx Implants, Inc.
Decision Date2001-02-20
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 2001-02-20 under 510(k) number K003659. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260?

PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 is a medical device that received FDA 510(k) clearance on 2001-02-20. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K003659.

When did PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 receive FDA 510(k) clearance?

PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 received FDA 510(k) clearance on 2001-02-20, under 510(k) number K003659.

Who is the listed applicant for PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260?

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

What is the FDA product code for PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260?

The FDA product code for PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 is HTY.

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Other records listing Bionx Implants, Inc. as applicant

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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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