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FDA 510(k)

CALYPSO SYSTEM

K-Number: K120564 · 2012-07-16

ApplicantHogan Lovells US LLP
Decision Date2012-07-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALYPSO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hogan Lovells US LLP. It received FDA 510(k) clearance on 2012-07-16 under 510(k) number K120564. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALYPSO SYSTEM?

CALYPSO SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-16. The listed applicant is Hogan Lovells US LLP. The 510(k) number is K120564.

When did CALYPSO SYSTEM receive FDA 510(k) clearance?

CALYPSO SYSTEM received FDA 510(k) clearance on 2012-07-16, under 510(k) number K120564.

Who is the listed applicant for CALYPSO SYSTEM?

The FDA 510(k) record lists Hogan Lovells US LLP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALYPSO SYSTEM?

The FDA product code for CALYPSO SYSTEM is NKB.

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 Hogan Lovells US LLP 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.

K132287JAZZ SYSTEM

Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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