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FDA 510(k)

MOTILITY ORBITAL IMPLANT

K-Number: K891137 · 1989-08-24

ApplicantIntegrated Orbital Implants, Inc.
Decision Date1989-08-24
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MOTILITY ORBITAL IMPLANT 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 1989-08-24 under 510(k) number K891137. 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 MOTILITY ORBITAL IMPLANT?

MOTILITY ORBITAL IMPLANT is a medical device that received FDA 510(k) clearance on 1989-08-24. The listed applicant is Integrated Orbital Implants, Inc.. The 510(k) number is K891137.

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

MOTILITY ORBITAL IMPLANT received FDA 510(k) clearance on 1989-08-24, under 510(k) number K891137.

Who is the listed applicant for MOTILITY ORBITAL IMPLANT?

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 MOTILITY ORBITAL IMPLANT?

The FDA product code for MOTILITY ORBITAL IMPLANT is HPZ.

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 CONFORMERK974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM

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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