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FDA 510(k)

BIOCERAMIC ORBITAL IMPLANT

K-Number: K992294 · 2000-04-19

ApplicantFci Ophthalmics, Inc.
Decision Date2000-04-19
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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 2000-04-19 under 510(k) number K992294. 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?

BIOCERAMIC ORBITAL IMPLANT is a medical device that received FDA 510(k) clearance on 2000-04-19. The listed applicant is Fci Ophthalmics, Inc.. The 510(k) number is K992294.

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

BIOCERAMIC ORBITAL IMPLANT received FDA 510(k) clearance on 2000-04-19, under 510(k) number K992294.

Who is the listed applicant for 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 BIOCERAMIC ORBITAL IMPLANT?

The FDA product code for 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)K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTK030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

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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

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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