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FDA 510(k)

PASS OCT Patient Specific Rods

K-Number: K153169 · 2016-01-29

ApplicantMedicrea International
Decision Date2016-01-29
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS OCT Patient Specific Rods is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K153169. 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 Patient Specific Rods?

PASS OCT Patient Specific Rods is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Medicrea International. The 510(k) number is K153169.

When did PASS OCT Patient Specific Rods receive FDA 510(k) clearance?

PASS OCT Patient Specific Rods received FDA 510(k) clearance on 2016-01-29, under 510(k) number K153169.

Who is the listed applicant for PASS OCT Patient Specific Rods?

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

What is the FDA product code for PASS OCT Patient Specific Rods?

The FDA product code for PASS OCT Patient Specific Rods is NKG.

Other records listing Medicrea International as applicant

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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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