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FDA 510(k)

JAZZ SYSTEM

K-Number: K132287 · 2013-09-25

ApplicantHogan Lovells US LLP
Decision Date2013-09-25
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ 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 2013-09-25 under 510(k) number K132287. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ SYSTEM?

JAZZ SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-25. The listed applicant is Hogan Lovells US LLP. The 510(k) number is K132287.

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

JAZZ SYSTEM received FDA 510(k) clearance on 2013-09-25, under 510(k) number K132287.

Who is the listed applicant for JAZZ 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 JAZZ SYSTEM?

The FDA product code for JAZZ SYSTEM is OWI.

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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.

K120564CALYPSO SYSTEM

Related Devices (Code: OWI)

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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K222097OLYMPIC Deformity Band SystemAstura MedicalK230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.

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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