Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JAZZ LOCK

K-Number: K153348 · 2016-03-31

ApplicantImplanet, S.A.
Decision Date2016-03-31
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ LOCK 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 2016-03-31 under 510(k) number K153348. 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 LOCK?

JAZZ LOCK is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Implanet, S.A.. The 510(k) number is K153348.

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

JAZZ LOCK received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153348.

Who is the listed applicant for JAZZ LOCK?

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 LOCK?

The FDA product code for JAZZ LOCK 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 BandK170730JAZZ System, including JAZZ Band

View all 9 devices →

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.

↑