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FDA 510(k)

ORBITAL RECONSTRUCTIVE IMPLANT

K-Number: K070130 · 2007-04-19

ApplicantBecker & Associates Consulting, Inc.
Decision Date2007-04-19
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBITAL RECONSTRUCTIVE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Becker & Associates Consulting, Inc.. It received FDA 510(k) clearance on 2007-04-19 under 510(k) number K070130. 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?

ORBITAL RECONSTRUCTIVE IMPLANT is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Becker & Associates Consulting, Inc.. The 510(k) number is K070130.

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

ORBITAL RECONSTRUCTIVE IMPLANT received FDA 510(k) clearance on 2007-04-19, under 510(k) number K070130.

Who is the listed applicant for ORBITAL RECONSTRUCTIVE IMPLANT?

The FDA 510(k) record lists Becker & Associates Consulting, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORBITAL RECONSTRUCTIVE IMPLANT?

The FDA product code for ORBITAL RECONSTRUCTIVE IMPLANT is HPZ.

Related Clinical Trials

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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