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FDA 510(k)

PLLA PIN

K-Number: K010983 · 2001-06-13

ApplicantBionx Implants, Inc.
Decision Date2001-06-13
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLLA PIN 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 2001-06-13 under 510(k) number K010983. 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 PLLA PIN?

PLLA PIN is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K010983.

When did PLLA PIN receive FDA 510(k) clearance?

PLLA PIN received FDA 510(k) clearance on 2001-06-13, under 510(k) number K010983.

Who is the listed applicant for PLLA PIN?

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 PLLA PIN?

The FDA product code for PLLA PIN is HTY.

Other records listing Bionx Implants, 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.

K023022NUGEN FX SCREWK011569BIOSORBFX O/M 2.0/2/4 SYSTEMK013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214K013057BIOCUFF,C, MODELS 236018, 236028, 236036K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116K010554MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

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Related Devices (Code: HTY)

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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