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FDA 510(k)

CORAL SPINAL SYSTEM

K-Number: K041592 · 2004-09-16

ApplicantTheken Surgical
Decision Date2004-09-16
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORAL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K041592. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORAL SPINAL SYSTEM?

CORAL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Theken Surgical. The 510(k) number is K041592.

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

CORAL SPINAL SYSTEM received FDA 510(k) clearance on 2004-09-16, under 510(k) number K041592.

Who is the listed applicant for CORAL SPINAL SYSTEM?

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

What is the FDA product code for CORAL SPINAL SYSTEM?

The FDA product code for CORAL SPINAL SYSTEM is KWP.

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 Theken Surgical 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.

K994382NONLINEAR TAPER LAG SCREWK994383DOGBONE ACFS

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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