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FDA 510(k)

PASS OCT Spinal System

K-Number: K161149 · 2016-07-11

ApplicantMedicrea International SA
Decision Date2016-07-11
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS OCT 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 2016-07-11 under 510(k) number K161149. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASS OCT Spinal System?

PASS OCT Spinal System is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Medicrea International SA. The 510(k) number is K161149.

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

PASS OCT Spinal System received FDA 510(k) clearance on 2016-07-11, under 510(k) number K161149.

Who is the listed applicant for PASS OCT 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 OCT Spinal System?

The FDA product code for PASS OCT Spinal System is NKG.

Other records listing Medicrea International SA 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.

K213659LigaPASS™ 2.0 Ligament Augmentation SystemK220810Infinity™ OCT System and PASS OCT Spinal SystemK220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemK212005UNiD Spine AnalyzerK213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemK210470C-CURVE Interbody Fusion Device

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Related Devices (Code: NKG)

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.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech 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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