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FDA 510(k)

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

K-Number: K000151 · 2000-04-10

ApplicantIntegrated Orbital Implants, Inc.
Decision Date2000-04-10
Product CodeMQU
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE 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 2000-04-10 under 510(k) number K000151. The device is classified under product code MQU. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE?

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Integrated Orbital Implants, Inc.. The 510(k) number is K000151.

When did PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE receive FDA 510(k) clearance?

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE received FDA 510(k) clearance on 2000-04-10, under 510(k) number K000151.

Who is the listed applicant for PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE?

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 PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE?

The FDA product code for PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE is MQU.

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.

K003338BIO-EYE II ORBITAL IMPLANTK982562BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERK974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMK891137MOTILITY ORBITAL IMPLANT

Related Devices (Code: MQU)

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.

K980822TITANIUM PEG SYSTEMFci Ophthalmics, Inc.K974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMIntegrated Orbital Implants, Inc.K971583MEDPOR OCULAR SCREW AND ACCEOSSORIESPorex Technologies Corp.

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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