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FDA 510(k)

MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM

K-Number: K100888 · 2010-11-15

ApplicantLanx, Inc.
Decision Date2010-11-15
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lanx, Inc.. It received FDA 510(k) clearance on 2010-11-15 under 510(k) number K100888. 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 MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM?

MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-15. The listed applicant is Lanx, Inc.. The 510(k) number is K100888.

When did MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2010-11-15, under 510(k) number K100888.

Who is the listed applicant for MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM?

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

What is the FDA product code for MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM?

The FDA product code for MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM is KWP.

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Other records listing Lanx, Inc. 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.

K131547LANX FUSION SYSTEMK131156LANX SPINAL FIXATION SYSTEMK123767LANX FUSION SYSTEM- SAK121316LANX SPINAL FIZATION SYSTEMK122145LANX SPINAL FIXATION SYSTEMK121940LANX SPINAL FIXATION SYSTEM

View all 23 devices →

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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