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FDA 510(k)

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

K-Number: K023400 · 2003-08-22

ApplicantFci Ophthalmics, Inc.
Decision Date2003-08-22
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Fci Ophthalmics, Inc.. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K023400. 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 FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT?

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K023400.

When did FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT receive FDA 510(k) clearance?

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT received FDA 510(k) clearance on 2003-08-22, under 510(k) number K023400.

Who is the listed applicant for FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT?

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

What is the FDA product code for FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT?

The FDA product code for FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT is HPZ.

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Other records listing Fci Ophthalmics, 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.

K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEK061398SNUG PLUG PUNCTUM PLUGK041869SELF RETAINING BICANALICULUS INTUBATION SETK023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESK992294BIOCERAMIC ORBITAL IMPLANT

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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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