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FDA 510(k)

JAZZ PF

K-Number: K191217 · 2019-08-02

ApplicantImplanet, S.A.
Decision Date2019-08-02
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ PF 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 2019-08-02 under 510(k) number K191217. 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 PF?

JAZZ PF is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Implanet, S.A.. The 510(k) number is K191217.

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

JAZZ PF received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191217.

Who is the listed applicant for JAZZ PF?

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 PF?

The FDA product code for JAZZ PF 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.

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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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