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FDA 510(k)

BIOCERAMIC ORBITAL IMPLANT, ORBTEX

K-Number: K110554 · 2011-11-02

ApplicantCeramisys, Ltd.
Decision Date2011-11-02
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIOCERAMIC ORBITAL IMPLANT, ORBTEX is the device name listed in this FDA 510(k) record. The listed applicant is Ceramisys, Ltd.. It received FDA 510(k) clearance on 2011-11-02 under 510(k) number K110554. 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 BIOCERAMIC ORBITAL IMPLANT, ORBTEX?

BIOCERAMIC ORBITAL IMPLANT, ORBTEX is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Ceramisys, Ltd.. The 510(k) number is K110554.

When did BIOCERAMIC ORBITAL IMPLANT, ORBTEX receive FDA 510(k) clearance?

BIOCERAMIC ORBITAL IMPLANT, ORBTEX received FDA 510(k) clearance on 2011-11-02, under 510(k) number K110554.

Who is the listed applicant for BIOCERAMIC ORBITAL IMPLANT, ORBTEX?

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

What is the FDA product code for BIOCERAMIC ORBITAL IMPLANT, ORBTEX?

The FDA product code for BIOCERAMIC ORBITAL IMPLANT, ORBTEX 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 Ceramisys, Ltd. 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.

K103820REPROBONE DENTAL GRAFTING MATERIAL

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.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLCK073293DURETTE IMPLANTOculo Plastik, Inc.

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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