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FDA 510(k)

PASS XS Spinal System

K-Number: K160640 · 2016-09-23

ApplicantMedicrea International SA
Decision Date2016-09-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS XS Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K160640. 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 PASS XS Spinal System?

PASS XS Spinal System is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Medicrea International SA. The 510(k) number is K160640.

When did PASS XS Spinal System receive FDA 510(k) clearance?

PASS XS Spinal System received FDA 510(k) clearance on 2016-09-23, under 510(k) number K160640.

Who is the listed applicant for PASS XS Spinal System?

The FDA 510(k) record lists Medicrea International SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASS XS Spinal System?

The FDA product code for PASS XS Spinal System is NKB.

Other records listing Medicrea International SA 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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