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FDA 510(k)

BIO-EYE II ORBITAL IMPLANT

K-Number: K003338 · 2001-02-07

ApplicantIntegrated Orbital Implants, Inc.
Decision Date2001-02-07
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIO-EYE II ORBITAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Orbital Implants, Inc.. It received FDA 510(k) clearance on 2001-02-07 under 510(k) number K003338. 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 BIO-EYE II ORBITAL IMPLANT?

BIO-EYE II ORBITAL IMPLANT is a medical device that received FDA 510(k) clearance on 2001-02-07. The listed applicant is Integrated Orbital Implants, Inc.. The 510(k) number is K003338.

When did BIO-EYE II ORBITAL IMPLANT receive FDA 510(k) clearance?

BIO-EYE II ORBITAL IMPLANT received FDA 510(k) clearance on 2001-02-07, under 510(k) number K003338.

Who is the listed applicant for BIO-EYE II ORBITAL IMPLANT?

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

What is the FDA product code for BIO-EYE II ORBITAL IMPLANT?

The FDA product code for BIO-EYE II 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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Other records listing Integrated Orbital 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.

K000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEK982562BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERK974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMK891137MOTILITY ORBITAL IMPLANT

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

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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