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FDA 510(k)

TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM

K-Number: K132504 · 2013-11-25

ApplicantCorelink, LLC
Decision Date2013-11-25
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2013-11-25 under 510(k) number K132504. 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 TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM?

TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Corelink, LLC. The 510(k) number is K132504.

When did TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2013-11-25, under 510(k) number K132504.

Who is the listed applicant for TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM?

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

What is the FDA product code for TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM?

The FDA product code for TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM is KWP.

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Other records listing Corelink, LLC as applicant

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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.K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEMMedtronic Sofamor Danek USA, 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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