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FDA 510(k)

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT

K-Number: K900930 · 1990-05-15

ApplicantOculo Plastik, Inc.
Decision Date1990-05-15
Product CodeHQX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Oculo Plastik, Inc.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K900930. The device is classified under product code HQX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIVEY-ALLEN ORBITAL FLOOR IMPLANT?

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K900930.

When did SPIVEY-ALLEN ORBITAL FLOOR IMPLANT receive FDA 510(k) clearance?

SPIVEY-ALLEN ORBITAL FLOOR IMPLANT received FDA 510(k) clearance on 1990-05-15, under 510(k) number K900930.

Who is the listed applicant for SPIVEY-ALLEN ORBITAL FLOOR IMPLANT?

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

What is the FDA product code for SPIVEY-ALLEN ORBITAL FLOOR IMPLANT?

The FDA product code for SPIVEY-ALLEN ORBITAL FLOOR IMPLANT is HQX.

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Other records listing Oculo Plastik, 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.

K123764DURETTE OCULAR IMPLANTK112176SILICONE SPHERESK073293DURETTE IMPLANTK040689EYE SPHERE IMPLANTSK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK915630OPHTIMPLANT

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Related Devices (Code: HQX)

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.

K023481MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.K983581OCU-GUARD AND OCU-GUARD SUPPLEBio-Vascular, Inc.K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESFci Ophthalmics, Inc.K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESFci Ophthalmics, Inc.K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)Storz Ophthalmics, Inc.

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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