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FDA 510(k)

JAZZ System, including JAZZ Band

K-Number: K170730 · 2017-06-09

ApplicantImplanet, S.A.
Decision Date2017-06-09
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ System, including JAZZ Band is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K170730. 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, including JAZZ Band?

JAZZ System, including JAZZ Band is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Implanet, S.A.. The 510(k) number is K170730.

When did JAZZ System, including JAZZ Band receive FDA 510(k) clearance?

JAZZ System, including JAZZ Band received FDA 510(k) clearance on 2017-06-09, under 510(k) number K170730.

Who is the listed applicant for JAZZ System, including JAZZ Band?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ System, including JAZZ Band?

The FDA product code for JAZZ System, including JAZZ Band is OWI.

Other records listing Implanet, S.A. 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.

K230026SQUALEK192084Madison Total Knee SystemK191217JAZZ PFK182771ISS-JAZZ Screw System and JAZZ CAP SPK171881JAZZ Passer BandK162764JAZZ FRAME SYSTEM

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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

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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