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FDA 510(k)

LANX DEFORMITY SYSTEM

K-Number: K071633 · 2007-08-15

ApplicantLanx, LLC
Decision Date2007-08-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LANX DEFORMITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lanx, LLC. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071633. 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 LANX DEFORMITY SYSTEM?

LANX DEFORMITY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Lanx, LLC. The 510(k) number is K071633.

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

LANX DEFORMITY SYSTEM received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071633.

Who is the listed applicant for LANX DEFORMITY SYSTEM?

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

What is the FDA product code for LANX DEFORMITY SYSTEM?

The FDA product code for LANX DEFORMITY SYSTEM is KWP.

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Other records listing Lanx, 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.

K120399LANX SPINAL FIXATION SYSTEMK102738LANX FUSION SYSTEMK103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)K093285MODIFICATION TO LANX SPINAL FIXATION SYSTEMK082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICEK073144LANX INTERVERTEBRAL BODY FUSION DEVICE

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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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