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FDA 510(k)

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM

K-Number: K974203 · 1998-02-04

ApplicantIntegrated Orbital Implants, Inc.
Decision Date1998-02-04
Product CodeMQU
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM 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 1998-02-04 under 510(k) number K974203. 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) TITANIUM MOTILITY/SUPPORT SYSTEM?

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-04. The listed applicant is Integrated Orbital Implants, Inc.. The 510(k) number is K974203.

When did PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM receive FDA 510(k) clearance?

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM received FDA 510(k) clearance on 1998-02-04, under 510(k) number K974203.

Who is the listed applicant for PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM?

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) TITANIUM MOTILITY/SUPPORT SYSTEM?

The FDA product code for PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 IMPLANTK000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEK982562BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERK891137MOTILITY 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.

K000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEIntegrated Orbital Implants, Inc.K980822TITANIUM PEG SYSTEMFci Ophthalmics, 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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