Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PASS ANTERIOR SPINAL SYSTEM

K-Number: K102406 · 2011-08-23

ApplicantMedicrea Technologies
Decision Date2011-08-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS ANTERIOR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea Technologies. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K102406. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASS ANTERIOR SPINAL SYSTEM?

PASS ANTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Medicrea Technologies. The 510(k) number is K102406.

When did PASS ANTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

PASS ANTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 2011-08-23, under 510(k) number K102406.

Who is the listed applicant for PASS ANTERIOR SPINAL SYSTEM?

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

What is the FDA product code for PASS ANTERIOR SPINAL SYSTEM?

The FDA product code for PASS ANTERIOR SPINAL SYSTEM is KWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medicrea Technologies 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.

K100544IMPIX LUMBAR INTERBODY DEVICEK083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBFK100297PASS LP SPINAL SYSTEMK083810PASS LP SPINAL SYSTEMK083308PASS LP SPINAL SYSTEMK082069PASS 2 SPINAL SYSTEM

View all 14 devices →

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.

↑