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FDA 510(k)

CORAL SPINAL SYSTEM

K-Number: K120047 · 2012-02-03

ApplicantTheken Spine, LLC
Decision Date2012-02-03
Product CodeNKB
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 Spine, LLC. It received FDA 510(k) clearance on 2012-02-03 under 510(k) number K120047. The device is classified under product code NKB. 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 2012-02-03. The listed applicant is Theken Spine, LLC. The 510(k) number is K120047.

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

CORAL SPINAL SYSTEM received FDA 510(k) clearance on 2012-02-03, under 510(k) number K120047.

Who is the listed applicant for CORAL SPINAL SYSTEM?

The FDA 510(k) record lists Theken Spine, LLC 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 NKB.

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Other records listing Theken Spine, LLC 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.

K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYK121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEK120829STAINLESS STEEL SPINAL SYSTEMK111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK103228PARAMOUNT R IBF DEVICEK102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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