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FDA 510(k)

DENALI DEFORMITY SYSTEM

K-Number: K052404 · 2006-05-23

ApplicantK2m, LLC
Decision Date2006-05-23
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DENALI DEFORMITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, LLC. It received FDA 510(k) clearance on 2006-05-23 under 510(k) number K052404. 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 DENALI DEFORMITY SYSTEM?

DENALI DEFORMITY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-05-23. The listed applicant is K2m, LLC. The 510(k) number is K052404.

When did DENALI DEFORMITY SYSTEM receive FDA 510(k) clearance?

DENALI DEFORMITY SYSTEM received FDA 510(k) clearance on 2006-05-23, under 510(k) number K052404.

Who is the listed applicant for DENALI DEFORMITY SYSTEM?

The FDA 510(k) record lists K2m, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENALI DEFORMITY SYSTEM?

The FDA product code for DENALI DEFORMITY SYSTEM is KWP.

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Other records listing K2m, 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.

K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK060442PYRENEES CERVICAL PLATE SYSTEMK052398MESA SPINAL SYSTEMK051531TECTONIC CERVICAL PLATE SYSTEMK051454ALEUTIAN SPACER SYSTEMK042635DENALI SPINE SYSTEM

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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.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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