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FDA 510(k)

ORBITAL RECONSTRUCTIVE IMPLANT II

K-Number: K083342 · 2009-03-12

ApplicantEvera Medical, Inc.
Decision Date2009-03-12
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBITAL RECONSTRUCTIVE IMPLANT II is the device name listed in this FDA 510(k) record. The listed applicant is Evera Medical, Inc.. It received FDA 510(k) clearance on 2009-03-12 under 510(k) number K083342. 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 ORBITAL RECONSTRUCTIVE IMPLANT II?

ORBITAL RECONSTRUCTIVE IMPLANT II is a medical device that received FDA 510(k) clearance on 2009-03-12. The listed applicant is Evera Medical, Inc.. The 510(k) number is K083342.

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

ORBITAL RECONSTRUCTIVE IMPLANT II received FDA 510(k) clearance on 2009-03-12, under 510(k) number K083342.

Who is the listed applicant for ORBITAL RECONSTRUCTIVE IMPLANT II?

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

What is the FDA product code for ORBITAL RECONSTRUCTIVE IMPLANT II?

The FDA product code for ORBITAL RECONSTRUCTIVE IMPLANT II 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 Evera Medical, 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.

K063154FACIAL RECONSTRUCTIVE MESH (FRM)

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.K082850EYE SPHERESProduct and Educational Services, LLCK073293DURETTE IMPLANTOculo Plastik, 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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