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FDA 510(k)

ISS-JAZZ Screw System and JAZZ CAP SP

K-Number: K182771 · 2019-03-12

ApplicantImplanet, S.A.
Decision Date2019-03-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISS-JAZZ Screw System and JAZZ CAP SP 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 2019-03-12 under 510(k) number K182771. 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 ISS-JAZZ Screw System and JAZZ CAP SP?

ISS-JAZZ Screw System and JAZZ CAP SP is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Implanet, S.A.. The 510(k) number is K182771.

When did ISS-JAZZ Screw System and JAZZ CAP SP receive FDA 510(k) clearance?

ISS-JAZZ Screw System and JAZZ CAP SP received FDA 510(k) clearance on 2019-03-12, under 510(k) number K182771.

Who is the listed applicant for ISS-JAZZ Screw System and JAZZ CAP SP?

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 ISS-JAZZ Screw System and JAZZ CAP SP?

The FDA product code for ISS-JAZZ Screw System and JAZZ CAP SP is NKB.

Other records listing Implanet, S.A. as applicant

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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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak 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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