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)

SYNTHES ORACLE PLATE

K-Number: K091159 · 2009-07-10

ApplicantSynthes Spine
Decision Date2009-07-10
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES ORACLE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2009-07-10 under 510(k) number K091159. 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 SYNTHES ORACLE PLATE?

SYNTHES ORACLE PLATE is a medical device that received FDA 510(k) clearance on 2009-07-10. The listed applicant is Synthes Spine. The 510(k) number is K091159.

When did SYNTHES ORACLE PLATE receive FDA 510(k) clearance?

SYNTHES ORACLE PLATE received FDA 510(k) clearance on 2009-07-10, under 510(k) number K091159.

Who is the listed applicant for SYNTHES ORACLE PLATE?

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

What is the FDA product code for SYNTHES ORACLE PLATE?

The FDA product code for SYNTHES ORACLE PLATE 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 Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

View all 36 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.

↑