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FDA 510(k)

HA ORBITAL IMPLANT

K-Number: K021643 · 2002-12-13

ApplicantLaboratoire Villanova
Decision Date2002-12-13
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HA ORBITAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoire Villanova. It received FDA 510(k) clearance on 2002-12-13 under 510(k) number K021643. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HA ORBITAL IMPLANT?

HA ORBITAL IMPLANT is a medical device that received FDA 510(k) clearance on 2002-12-13. The listed applicant is Laboratoire Villanova. The 510(k) number is K021643.

When did HA ORBITAL IMPLANT receive FDA 510(k) clearance?

HA ORBITAL IMPLANT received FDA 510(k) clearance on 2002-12-13, under 510(k) number K021643.

Who is the listed applicant for HA ORBITAL IMPLANT?

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

What is the FDA product code for HA ORBITAL IMPLANT?

The FDA product code for HA ORBITAL IMPLANT is HPZ.

Related Clinical Trials

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: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

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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