FDA 510(k)

PASS OCT Patient Specific Rods

K-Number: K153169 · 2016-01-29

Decision Date2016-01-29

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PASS OCT Patient Specific Rods is a medical device manufactured by Medicrea International. It received FDA 510(k) clearance on 2016-01-29 under approval 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. It is manufactured by Medicrea International. The 510(k) number is K153169.

When was PASS OCT Patient Specific Rods approved by the FDA?

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

What company makes PASS OCT Patient Specific Rods?

PASS OCT Patient Specific Rods is manufactured by Medicrea International.

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

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

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

Other Devices by Medicrea International

K170172UNiD Spine Analyzer K180091UNiD Spine Analyzer K220810Infinity OCT System and PASS OCT Spinal System K220724CD Horizon Spinal System and PASS LP Spinal System

Related Devices (Code: NKG)

K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.